©Nutriset2014 All rights reserved

Transcription

©Nutriset2014 All rights reserved
©Nutriset2014 All rights reserved
Who is this booklet intended for?
This document is addressed to logisticians, procurement, program and nutrition officers
working in country/regional offices or headquarters of national/international organizations,
donor agencies or ministries.
Why such a booklet?
The objective of this booklet is to provide humanitarian and social stakeholders with all the
necessary information about Plumpy’Nut to successfully procure and integrate this product
into their nutrition programs.
How is it structured?
The first chapter provides a description of the product, its context and concept. Chapters 2
and 3 detail the product’s ingredients, nutritional value, and give information for use
(recommended dosage, duration and use). Quality and packaging considerations are
discussed in the subsequent chapters 4 and 5. Product-related studies and references are
given to explain the scientific evidences supporting the use of Plumpy’Nut today. Finally, this
booklet provides answers to “Frequently Asked Questions.”
Plumpy’Nut® is a registered trademark of Nutriset, patent IRD/Nutriset.
Plumpy’Soy™ and Plumpy’Sup™ are Nutriset products trademarks.
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INDEX
1 PRODUCT DESCRIPTION..................................................................................................................4
1.1 Short description..........................................................................................................................4
1.2 Context (nutrition issue and determinants)..................................................................................4
1.3 Background of product development...........................................................................................4
1.4 Product concept and benefit........................................................................................................5
1.5 Context of use...............................................................................................................................6
2 INGREDIENTS AND NUTRITIONAL VALUE........................................................................................7
2.1 Ingredients....................................................................................................................................7
2.2 Nutrition facts...............................................................................................................................8
3 RECOMMENDED DOSAGE, DURATION & USE.................................................................................9
3.1 Target group.................................................................................................................................9
3.2 Recommended daily dose.............................................................................................................9
3.3 Duration of treatment..................................................................................................................9
3.4 Recommendations for use..........................................................................................................10
4 QUALITY CONSIDERATIONS..........................................................................................................11
4.1 Raw materials and packaging .....................................................................................................11
4.2 Quality Control ...........................................................................................................................11
4.3 Traceability ................................................................................................................................12
4.4 Certificates .................................................................................................................................12
4.5 Stability, Best Before Date (BBD) ...............................................................................................13
4.6 Conservation and storage...........................................................................................................13
5 PACKAGING CONSIDERATIONS.....................................................................................................14
5.1 Primary packaging design...........................................................................................................14
5.2 Technical and legal information on primary packaging..............................................................14
5.3 Secondary packaging design.......................................................................................................15
5.4 Technical and legal information on secondary packaging..........................................................15
5.5 Leaflet ........................................................................................................................................16
6 EVIDENCE SUPPORTING THE USE OF PLUMPY’NUT.......................................................................17
6.1 Finalized studies.........................................................................................................................17
6.2 Where Plumpy’Nut has been distributed...................................................................................27
6.3 Related references......................................................................................................................27
7 PRODUCTION ...............................................................................................................................31
7.1 Global Production.......................................................................................................................31
7.2 Local Production.........................................................................................................................31
8 FAQs.............................................................................................................................................34
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1
1.1
PRODUCT DESCRIPTION
Short description
Plumpy’Nut is a Ready-to-Use food, especially designed for the nutritional rehabilitation of
severe acute malnutrition in children over 6 months of age.
Plumpy’Nut corresponds to the definition of “RUTF” (Ready-to-Use Therapeutic Food) that
can be found in scientific literature related to the treatment of severe acute malnutrition.
1.2
Context (nutrition issue and determinants)
During the first years of life, children living in developing countries are most at risk of
undernutrition. It is crucial to correct the nutritional status in these young age groups as
soon as possible because it is an important period of growth and development. Malnutrition
has a direct impact on the physical and psychological development of individuals, and acute
malnutrition, the most serious degree of malnutrition, is associated with an increased risk of
morbidity and infant mortality.
1.3
Background of product development
Since the 1990s, the management of severe acute malnutrition has been conducted using
therapeutic milks (F-75 for stabilization and F-100 for catch-up growth). Therapeutic milk
powder can only be used in therapeutic feeding centres (TFCs) where its safe preparation
and utilization is ensured by a close supervision. Milk powder has to be diluted with potable
water (boiled if necessary) and consumed within a limited time period to constrict bacterial
growth.
To ensure a more practical way of treating severe acute malnutrition Plumpy’Nut was
developed in 1996, as a Ready-to-Use Therapeutic Food with the same nutritional value as
the F-100. Because it can be used at home without any preparation, under the supervision of
the mother or another member of the family, Plumpy’Nut® makes it possible to treat the
majority of children suffering from severe acute malnutrition without hospitalization.
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1.4
Product concept and benefit
Children who fall under the cut-off for severe acute malnutrition (using Mid Upper Arm
Circumference, Weight for Height measurement, and/or the presence of nutritional
oedema) need to receive an adapted diet that allows them to regain a normal nutritional
status. The diet needs to account for a malnourished child’s elevated nutrient and energy
requirements for catch-up growth.
Because Plumpy’Nut does not need to be mixed with water and has shown to be resistant to
bacterial contamination due to its low water activity 7,1 its invention induced a deep change in
the management of acute malnutrition by making outpatient care possible for acutely
malnourished children with appetite and without medical complications. Home treatment
with only weekly supervision reduces the burden on the families (opportunity costs) as well
as the costs of TFC management, while increasing treatment coverage. 2,3,4,5,6,7,8
1Briend A “Highly nutrient-dense spreads: a new approach to delivering multiple micronutrients to high risk groups.” Br J
Nutr (2001); 85: S175-179.
2Collins S and Sadler K. “0utpatients care for severely malnourished children in emergency relief programmes: a
retrospective cohort study.” The Lancet (2002); 360:1824-30.
3Collins S. “Changing the way we address severe malnutrition during famine.” The Lancet (2001); 358:498-501.
4Collins S. “Ambulatory treatment of severe malnutrition.” Field Exchange, (July 2003) Issue 19.
5Nestel P et al. “Complementary Food Supplements to achieve Micronutrient Adequacy for infants and young children.”
Extract. J Pediatr Gastroenterol Nut (2003); 36:346-328.
6Manary MJ et al. “Home based therapy for severe malnutrition with ready-to-use food.” Arch Dis Child (2004); 89: 557-61.
7Ciliberto MA. “Home-based therapy for oedematous malnutrition with ready-to-use therapeutic food.” P. Acta Paediatr
(2006), 95:1012-5.
8Briend A et al. “Ready-to-Use therapeutic food for treatment of marasmus.” The Lancet (1999); 353:1767-8.
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1.5
Context of use
The diagram below shows how Plumpy’Nut is used within the various intervention
programs.
Figure 1 : Plumpy’Nut® used in phase 2 of therapeutic care of patients suffering from severe acute malnutrition
As shown in figure 1, Plumpy’Nut is used during the nutritional rehabilitation phase (phase 2)
in CMAM (Community-Based Management of Acute malnutrition) programs.
As shown by Diop et al (2003) when comparing it to F-100, Plumpy’Nut is not only preferred
by children, it also holds a much lower risk of contamination and severely malnourished
children consuming it show higher weight gains than those receiving F-100 therapeutic milk. 9
However therapeutic milk F-100 is still the product of reference when it comes to treat
severely acutely malnourished children that have medical complications.
Several studies have demonstrated that Plumpy’Nut is efficacious in treating severe as well
as moderate acute malnutrition.9,10 In order to improve cost effectiveness of the treatment,
other products dedicated to the treatment of moderate acute malnutrition have been
developed (for more information, please refer to booklet for Plumpy’Sup).
9Diop el HI et al. “Comparison of the efficacy of solid ready-to-use and a liquid, milk-based diet for the rehabilitation of
severely malnourished children: a randomised trial.” Am J Clin Nutr (2003); 78:307-7.
10Ciliberto MA et al. “Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the
treatment of malnourished Malawian children: a controlled, clinical effectiveness trial.” Am J Clin Nutr (2005); 81, 864–870.
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2
2.1
INGREDIENTS AND NUTRITIONAL VALUE
Ingredients
Plumpy’Nut is made out of peanuts, non-hydrogenated vegetable fat (palm, rapeseed),
sugar, skimmed milk powder, whey powder, maltodextrin (wheat or corn), vitamin and
mineral complex, emulsifiers: vegetable lecithin (soy or sunflower), mono and diglycerides,
and stabilizers: hydrogenated vegetable fat.
Plumpy’Nut contains the following potential allergens: peanuts, milk and milk products.
Plumpy’Nut may also contain traces of soy.
Plumpy’Nut does not contain any Genetically Modified Organism (GMO). It does not
contain any ingredients of animal origin, except dairy products.
Note: Plumpy’Nut is a paste of light brown to orange brown colour, with typical flavour
and odour of peanut and milk.
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2.2
Nutrition facts
For 100g of Plumpy’Nut
Energy
Proteins
(% of total energy )
Proteins
Min
Max
For 92 g
(serving size)
520 kcal
550 kcal
500 kcal
10% of energy
12% of energy
13 g
50 % of total
% of milk proteins
proteins
For 100g of Plumpy’Nut
Min
Max
For 92 g
(serving size)
Iron
10 mg
14 mg
10,6 mg
10% of energy
Iodine
70 µg
140 µg
92 µg
16 g
12.1 g
Selenium
20 µg
40 µg
27.6 µg
-
> 50 % of total
proteins
Sodium
-
290 mg
< 267 mg
Vitamin A
800 µg
1200 µg
840 µg
PDC AAS
( P r o t e in
D ig e s t ib ilit y C o r r e c t e d A m in o
A c id S c o r e )
Lipids
(% of total energy )
Lipids
Fatty acid n-6
> 0.95
-
1
45% of energy
60% of energy
56% of energy
Vitamin D
15 µg
20 µg
15 µg
26 g
36 g
29.9 g
Vitamin E
20 mg
40 mg
18,4 mg
3% of energy
10% of energy
≈7%
Vitamin C
50 mg
132 mg
49 mg
Vitamin B1
0,5 mg
1,5 mg
0,55 mg
Vitamin B2
1,6 mg
3,0 mg
1,66 mg
(= 4 g)
(% of total energy )
Fatty acid n-3
≈ 0.7 %
0.3% of energy
2.5% of energy
(= 0.35 g)
(% of total energy )
45 g
C arbohy drates
41 g
58 g
Fibre content
-
< 5%
< 5%
Vitamin B6
0,6 mg
0,9 mg
0,55 mg
M oisture
-
2.5 %
2.5 %
Vitamin B12
1,6 µg
3,0 µg
1.7 µg
C alcium
300 mg
500 mg
276 mg
Vitamin K
15 µg
30 µg
19,3 µg
Phosphorus
300 mg
500 mg
276 mg
Biotin
60 µg
90 µg
60 µg
Potassium
1100 mg
1400 mg
1022 mg
Folic acid
200 µg
400 µg
193 µg
M agnesium
80 mg
100 mg
84,6 mg
Pantothenic acid
3 mg
6 mg
2,85 mg
Zinc
11 mg
14 mg
12,9 mg
N iacin
5 mg
9 mg
4,88 mg
C opper
1,4 mg
1,8 mg
1,6 mg
(≈ 36% of total
energy )
Note: Trans fatty acids < 3% of total fatty acids
Plumpy’Nut complies with the specifications set in UN Agencies’ joint statement «Community-based
management of severe acute malnutrition» published in May 2007 11.
11Community-based Management of Severe Acute Malnutrition A Joint Statement by the World Health Organization, the
World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children’s
Fund, May 2007.
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3
RECOMMENDED DOSAGE, DURATION & USE
3.1
Target group
1) Primary target group:

Children 6 - 59 months of age suffering from Severe Acute Malnutrition 12
2) Secondary target group:


3.2
Children 6-59 months of age suffering from Moderate Acute Malnutrition
Adults suffering from severe acute malnutrition 13
Recommended daily dose
Inpatient transition phase:
- after stabilisation with F-75 when moving to rehabilitation:
100 - 135 kcal/kg body weight / day (for 2-3 days before complete transition to outpatient
care)
Outpatient treatment:
200 kcal/kg body weight /day (>130 kcal/kg body weight / day)*
Providing about all of the child’s energy and nutrient requirements in addition to breast milk.
Recommended
quantities
of
Plumpy’Nut
Severe Acute Malnutrition
Moderate Acute Malnutrition
200 kcal / kg body weight / day
75kcal / kg body weight/ day
the standard regimen is 2 sachets per day for a child
between 5 and 6.9 kg, 3 sachets for a child between 7 and
9.9 kg and 4 sachets for a child more than 10 kg
That is about 1 sachet per day for a
moderately acutely malnourished child
weighting 7 kg
*Recommended amount of energy and nutrients according to WHO protocol for the treatment of severe
malnutrition with F-100 therapeutic milk.14
3.3
Duration of treatment
Nutritional treatment is necessary until the child reaches the discharge criteria (e.g. MUAC)
and is considered recovered 13, which may take from 4 to 10 weeks, depending on the
programme’s context and performance.
12Diop el HI et al. “Home-based rehabilitation for Severely Malnourished Children Using Locally Made Ready-to-Use
Therapeutic Food (RUTF)” Reports from the 2 nd World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.
Paris (France), (July 3-7, 2004). Medimond, Monduzzi Editore (international Proceedings) pp. 101-105.
13Navarro-Colorado C et al. “Comparison of a liquid and solid diet for the rehabilitation of severely malnourished adults: a
clinical trial.” Submitted to the European Journal of Clinical Nutrition
14WHO. "Management of severe malnutrition: a manual for physicians and other senior health workers". 1999
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3.4
Recommendations for use
Plumpy’Nut has to be prescribed and initiated by trained health and nutrition professionals
only. Severely malnourished children are treated under medical supervision. Medical
supervision can be provided as inpatient or outpatient care. Severely malnourished children
treated with Plumpy’Nut should receive regular check-ups by a health practitioner prior to
receiving their next ration of Plumpy’Nut.
Plumpy’Nut is a ready to use therapeutic food (RUTF) and can be consumed directly from the
sachet without prior cooking, or dilution with water. The product can easily be opened by
tearing off one corner of the sachet
The sachets of Plumpy’Nut can be used by a child on their own, without any assistance. After
opening, the sachet has to be consumed within 24 hours.
Plumpy’Nut should not be given to people who are allergic to cow milk or peanuts.
Plumpy’Nut is not likely to increase the child’s need for water 15, but it is recommended to
have potable water available for the child when consuming Plumpy’Nut.
Plumpy’Nut should not be shared with other people in the family, because it could reduce
the amount the child would consume, which may no longer be sufficient to satisfy the child’s
needs.
Plumpy’Nut is not adapted for well-nourished children nor adults.
The use of Plumpy’Nut should be limited to the treatment of malnutrition.
Plumpy’Nut must not replace breastfeeding. Children under 2 years of age receiving
Plumpy’Nut should continue to receive breastmilk.
Breastfeeding is recommanded for at least 24 months, and exclusively for the
first 6 months of age.
15Collins S and Sadler K. “0utpatients care for severely malnourished children in emergency relief programmes: a
retrospective cohort study.” The Lancet (2002); 360:1824-30.
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4
QUALITY CONSIDERATIONS
The Quality Management System set up by Nutriset is based on International standards (ISO
22 000:2005) and Recommendations of Codex Alimentarius (HACCP method).
4.1
Raw materials and packaging
Plumpy’Nut is packaged under protective atmosphere in order to optimize the product’s
shelf life, and sachets are air and humidity tight.
Plumpy’Nut complies with the “Guidelines for Formulated Supplementary Foods for Older
Infants and Young Children” of the Codex Alimentarius CAC/GL 08-1991.
All added mineral salts and vitamins included in Plumpy’Nut are on the “Advisory Lists of
Nutrient Compounds for Use in Foods for Special Dietary Uses intended for Infants and
Young Children” of the Codex Alimentarius Standard CAC/GL 10-1979 (amended 1983, 1991,
2009).
All raw materials are “food grade” in compliance with general recommendations of Codex
Alimentarius (STAN 200-1995, STAN 207-1999, STAN 212-1999).
Packaging material of the sachet is suitable for food contact according to European
Regulation 1935/2004, 27th October 2004.
4.2
Quality Control
Plumpy’Nut complies with the microbiological criteria recommended by the document
«Community-based management of severe acute malnutrition»16 and/or the « Arrêté du 1
juillet 1976 relatif aux aliments destinés aux nourrissons et aux enfants en bas âge, version
consolidée au 26 février 2005 » from French regulations.
A Quality Control Plan is defined for Plumpy’Nut, including analyses and tests of raw
material/ packaging and end product:

Bacteriological analyses (Salmonella, Enterobacteriaceae, Total count plate, E. coli,
Staphylococcus aureus, anaerobic sulfito-reductor, Yeast, Moulds, Listeria,
Cronobacter sakazakii…) ;

Chemical analyses (Proteins, Lipids, Chlorides, vitamin C…) ;

Physical analyses (odour, colour, taste…) ;

Checks on production line (leaks, printing…).
16UNICEF, WHO, WFP, UNSCN. “Community-based management of severe acute malnutrition, A Joint Statement.” 2007
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4.3
Traceability
The Quality management system guarantees up- and downstream traceability of
Plumpy’Nut:

The batches of raw materials used, as well as further information related to the
production (equipment used, production operators…) can be tracked back from the
end product.

From a batch of raw materials, it is possible to identify the batches of manufactured
end products and their destination.
For Nuriset, a batch mark corresponds to one day of production while it is one week for the
PlumpyField members.
The batch number is defined as follow:
4.4
Certificates
Nutriset can supply various documents related to a particular batch:

Certificate of analysis: summarizes the results of analysis that allowed the release of
the batch. Methods of analysis are described.

Certificate of conformity: clarifies the criteria and specifications related to the
product.

Health and non-radioactivity certificates can be issued from the information
communicated by the raw material suppliers.

Others certificates can be provided upon request (Non-GMO certificate, certificate of
origin...)
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4.5
Stability, Best Before Date (BBD)
The best before date (BBD) of Plumpy’Nut is based on Nutriset’s research since the late
1990’s and guarantees physicochemical stability and the content of each specified nutrient
for 24 months from the date of manufacture.
A vitamin and mineral premix has been formulated for Plumpy’Nut. The level of each
element has been defined according to their individual stability during storage to ensure
Plumpy’Nut specifications.
Plumpy’Nut ingredients include technological additives that guarantee the physical stability
of the product (no oil separation), and its organoleptic and nutritional properties during
storage.
Sachets are sealed under nitrogen atmosphere, to limit oxidation.
Best before date (« BB ») is 24 months from the manufacturing date stated on each sachet.
4.6
Conservation and storage
Plumpy’Nut should be stored in a dry and cool place, at a temperature below 30°C (86°F),
away from direct sunlight.
Reducing the Best Before date by 1/3 is recommended when storage temperature is
between 30 and 40°C, and by half when storage temperature is over 40°C.
It is recommended not to stack the pallets.
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5
5.1
PACKAGING CONSIDERATIONS
Primary packaging design
In order to facilitate distribution, use and understanding of the product in the field, key
messages related to the product have been defined. Visual aids such as pictograms help to
convey these messages:
5.2
Technical and legal information on primary packaging
Each sachet contains 92 g and provides 500 kcal.
All technical and legal information is indicated on the sachet, in 3 languages (French, English
and Spanish):
14

Name of the product

Target

List of ingredients

Net weight

Kilocalories content

Name and address of the manufacturer

Batch identification, Production date and Best Before date

Storage instructions

Instructions for use
5.3
Secondary packaging design
The same key messages (and visual aids) appear on the carton.
The shipping cartons are designed to withstand long transport times and multiple handlings.
Their size was chosen to optimize the various possible kinds of shipment.
5.4
Technical and legal information on secondary packaging
The following technical and legal information is indicated on the carton, in 3 languages
(French, English and Spanish):

Name of the product

Target

Estimated net weight and gross weight of the carton

Approximate number of sachets per carton, and kilocalories per sachet
15

Storage instructions

Instructions for use

Name and address of the manufacturer

Batch identification, Production date and Best Before date
5.5
Leaflet
The following technical and legal information is indicated on a separate leaflet present in
every secondary packaging, in 3 languages (French, English and Spanish):

Detailed nutritional information

Target

Instructions for use

Recommended dosage

Storage instructions

List of ingredients

Mean nutritional value

Name, address and contact details of the manufacturer
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6
6.1
EVIDENCE SUPPORTING THE USE OF PLUMPY’NUT
Finalized studies
Please find below a non-exhaustive list of references:
Acceptability of Plumpy’Nut
 Briend A et al. “Ready-to-use therapeutic food for treatment of marasmus.” Lancet (1999);
353: 1767-8.
 Dube B et al. "Comparison of Ready-to-Use Therapeutic Food with Cereal Legume-based
Khichri Among Malnourished Children”, Indian Paediatrics (2009); 46:383-8
Objective: To compare the acceptability and energy intake of Ready-to-Use Therapeutic Food
(RUTF) with cereal legume based khichri among malnourished children.
Subjects: 31 children aged ≥6 to ≤36 months with malnutrition, defined as Weight for height
(WHZ) <–2 to ≥–3 SD, with no clinical signs of infection or edema.
Intervention: Children were offered weighed amounts of RUTF and khichri in unlimited amounts
for 2 days, one meal of each on both days. Water was fed on demand. Caregivers’ interviews and
observations were conducted on the second day.
Outcome Measures: Acceptability of RUTF compared to khichri based on direct observation and
energy intake for test and control meals.
Results: The proportion of children who accepted RUTF eagerly was 58% as against 77% for
khichri. 42% children on RUTF and 23% on khichri accepted the meal but not eagerly. The median
(IQR) energy intake over the two day period in children aged 6 to 36 months from RUTF was 305
(153, 534) kcal, and from khichri was 242 (150, 320) kcal (P=0.02).
Conclusion: RUTF and khichri were both well accepted by study children. The energy intake from
RUTF was higher due to its extra energy density.
 Nga TT et al. Acceptability and impact on anthropometry of a locally developed ready-to-use
therapeutic food in pre-school children in Vietnam. Nutr J. 2013; 12:120.
BACKGROUND: In South East Asia, concerns exist about the acceptability of peanut-based Readyto-Use-Therapeutic-Foods (RUTF) for the treatment of severe acute malnutrition (SAM).
Therefore, an alternative, culturally acceptable RUTF made from locally available ingredients and
complying with local food traditions and preferences was developed. The current study
evaluated its acceptability and impact on anthropometry.
METHODS: The study was a randomized, two-arm, cross-over intervention trial to test
the acceptability of the local product (bar) against a commercially available, peanutbased RUTF paste (Plumpy'nut). Children (n = 67) from two kindergartens in a rural area of North
Vietnam were recruited. The age of the children was between 3 and 5 years.
RESULTS: The Vietnamese RUTF was well-accepted, although overall acceptability was less than
of Plumpy'nut, with the latter scoring higher on palatability (P < 0.05). In contrast, reluctance to
eat Plumpy'nut was higher than for the Vietnamese RUTF (P < 0.05). Impact on anthropmetrical
indices was similar for both RUTF. The nutritional status of the children who consumed the
twoRUTF over a 4 week period improved significantly, with a mean weight gain of 0.64 (SD 0.27)
Kg, and increases in WHZ and HAZ z-scores of 0.48 (SD 0.30) and 0.05 (SD 0.13) respectively (P < 0.01 both). Weight gain was similar between the 2 products (0.32 kg per 2 weeks for both).
17
CONCLUSIONS: Both the commercial Plumpy'nut and the local produced RUTF were accepted
although the harder consistency of the local product might have caused the lower overall
acceptance. The promising increase in nutritional status needs to be confirmed in a controlled
trial in children with SAM
Efficacy trials of Plumpy’Nut in hospital settings
 Diop el HI et al. “Comparison of the efficacy of a solid ready-to-use food and a liquid, milkbased diet for the rehabilitation of severely malnourished children: a randomized trial.” Am J
Clin Nutr. (2003); 78: 302-7.
Background: The World Health Organization recommends a liquid, milk-based diet (F100) during
the rehabilitation phase of the treatment of severe malnutrition. A dry, solid, ready-to-use food
(RTUF) that can be eaten without adding water has been proposed to eliminate the risk of
bacterial contamination from added water. The efficacies of RTUF and F100 have not been yet
compared.
Objective: The objective was to compare the efficacy of RTUF and F100 in promoting weight gain
in malnourished children.
Design: In an open-labelled, randomized trial, 70 severely malnourished Senegalese children
aged 6-36 mo were randomly allocated to receive 3 meals containing either F100 (n = 35) or
RUTF (n = 35) in addition to the local diet. The data from 30 children in each group were
analyzed.
Results: The mean (+/- SD) daily energy intake in the RTUF group was 808 +/- 280 (95% CI: 703.8,
912.9) kJ x kg body wt(-1) x d(-1), and that in the F100 group was 573 +/- 201 (95% CI: 497.9,
648.7) kJ. kg body wt(-1) x d(-1) (P < 0.001). The average weight gains in the RTUF and F100
groups were 15.6 (95% CI: 13.4, 17.8) and 10.1 (95% CI: 8.7, 11.4) g x kg body wt(-1) x d(-1),
respectively (P < 0.001). The difference in weight gain was greater in the most wasted children (P
< 0.05). The average duration of rehabilitation was 17.3 (95% CI: 15.6, 19.0) d in the F100 group
and was 13.4 (95% CI: 12.1, 14.7) d in the RTUF group (P < 0.001).
Conclusions: This study indicated that RTUF can be used efficiently for the rehabilitation of
severely malnourished children.
Efficacy & effectiveness of Plumpy’Nut in the community
 Ashworth A. “Efficacy and effectiveness of community-based treatment of severe
malnutrition.” Food Nutr. Bull. (2006); 27:S24-48.
Background. There is a long tradition of community based rehabilitation for treatment of severe
malnutrition: the question is whether it is effective and whether it should be advised for routine
health systems.
Objective. To examine the effectiveness of rehabilitating severely malnourished children in the
community in nonemergency situations.
Methods. A literature search was conducted of community-based rehabilitation programs
delivered by day-care nutrition centers, residential nutrition centers, primary health clinics, and
domiciliary care with or without provision of food, for the period 1980–2005. Effectiveness was
defined as mortality of less than 5% and an average weight gain of at least 5 g/kg/day.
Results. Thirty-three studies of community-based rehabilitation were examined and summarized.
Eleven (33%) programs were considered effective. Of the subsample of programs reported since
1995, 8 of 13 (62%) were effective. None of the programs operating within routine health
systems without external assistance was effective.
18
Conclusions. With careful planning and resources, all four delivery systems can be effective. It is
unlikely that a single delivery system would suit all situations worldwide. The choice of a system
depends on local factors. High energy intakes (> 150 kcal/kg/day), high protein intakes (4–6
g/kg/day), and provision of micronutrients are essential for success. When done well,
rehabilitation at home with family foods is more cost-effective than inpatient care, but the cost
effectiveness of ready-to-use therapeutic foods (RUTF) versus family foods has not been studied.
Where children have access to a functioning primary health-care system and can be monitored,
the rehabilitation phase of treatment of severe malnutrition should take place in the community
rather than in the hospital but only if caregivers can make energy- and protein-dense food
mixtures or are given RUTF. For routine health services, the cost of RUTF, logistics of
procurement and distribution, and sustainability need to be carefully considered.
 Ciliberto MA. “Home-based therapy for oedematous malnutrition with ready-to-use
therapeutic food.” P. Acta Paediatr. (2006); 95:1012-5.
Background:
Standard recommendations are that children with oedematous malnutrition receive inpatient
therapy with a graduated feeding regimen. Aim: To investigate exclusive home-based therapy for
children with oedematous malnutrition.
Methods:
Children with oedematous malnutrition, good appetite and no complications were treated at
home with ready-to-use therapeutic food (RUTF) and followed up fortnightly for up to 8 wk.
Setting and participants: 219 children aged 1-5 y with oedema enrolled in one of two therapeutic
nutritional studies in Malawi in 2003-2004.
Results:
The overall recovery rate was 83% (182/219), and the case-fatality rate was 5% (11/219). For
children with wasting and oedematous malnutrition, 65% (55/85) recovered and 7% (6/85) died.
The average weight gain was 2.8+/-3.2 g/kg/d (mean+/-SD).
Conclusion:
This preliminary observation suggests that children with oedematous malnutrition and good
appetite may be successfully treated with home-based therapy; a randomized, controlled trial to
evaluate this is warranted.
 Ciliberto MA et al. “A comparison of home-based therapy with ready-to-use therapeutic food
with standard therapy in the treatment of malnourished Malawian children: a controlled,
clinical effectiveness trial.” Am J Clin Nutr (2005); 81: 864-70.
Background: Childhood malnutrition is common in Malawi, and the standard treatment, which
follows international guidelines, results in poor recovery rates. Higher recovery rates have been
seen in pilot studies of home-based therapy with ready-to-use therapeutic food (RUTF).
Objectives: The objective was to compare the recovery rates among children with moderate and
severe wasting, kwashiorkor, or both receiving either home-based therapy with RUTF or standard
inpatient therapy.
Design: A controlled, comparative, clinical effectiveness trial was conducted in southern Malawi
with 1178 malnourished children. Children were systematically allocated to either standard
therapy (186 children) or home-based therapy with RUTF (992 children) according to a stepped
wedge design to control for bias introduced by the season of the year. Recovery, defined as
reaching a weight-for-height z score > -2, and relapse or death were the primary outcomes. The
rate of weight gain and the prevalence of fever, cough, and diarrhea were the secondary
outcomes.
Results: Children who received home-based therapy with RUTF were more likely to achieve a
weight-for-height z score > -2 than were those who received standard therapy (79% compared
with 46%; P < 0.001) and were less likely to relapse or die (8.7% compared with 16.7%; P <
19
0.001). Children who received home-based therapy with RUTF had greater rates of weight gain
(3.5 compared with 2.0 g . kg(-1) . d(-1); difference: 1.5; 95% CI: 1.0, 2.0 g . kg(-1) . d(-1)) and a
lower prevalence of fever, cough, and diarrhea than did children who received standard therapy.
Conclusion: Home-based therapy with RUTF is associated with better outcomes for childhood
malnutrition than is standard therapy.
 Collins S and Sadler K. “Outpatient care for severely malnourished children in emergency relief
programmes: a retrospective cohort study.” Lancet (2002); 360: 1824-30.
Background: In emergency nutritional relief programmes, therapeutic feeding centres are the
accepted intervention for the treatment of severely malnourished people. These centres often
cannot treat all the people requiring care. Consequently, coverage of therapeutic feeding centre
programmes can be low, reducing their effectiveness. We aimed to assess the effectiveness of
outpatient treatment for severe malnutrition in an emergency relief programme.
Methods: We did a retrospective cohort study in an outpatient therapeutic feeding programme
in Ethiopia from September, 2000, to January, 2001. We assessed clinical records for 170 children
aged 6-120 months. The children had either marasmus, kwashiorkor, or marasmic kwashiorkor.
Outcomes were mortality, default from programme, discharge from programme, rate of weight
gain, and length of stay in programme.
Findings: 144 (85%) patients recovered, seven (4%) died, 11 (6%) were transferred, and eight
(5%) defaulted. Median time to discharge was 42 days (IQR 28-56), days to death 14 (7-26), and
days to default 14 (7-28). Median rate of weight gain was 3.16 g kg(-1) x day(-1) (1.86-5.60). In
patients who recovered, median rates of weight gain were 4.80 g kg(-1) day(-1) (2.95-8.07) for
marasmic patients, 4.03 g x kg(-1) x day(-1) (2.68-4.29) for marasmic - kwashiorkor patients, and
2.70 g x kg(-1) x day(-1) (0.00-4.76) for kwashiorkor patients.
Interpretation: Outpatient treatment exceeded internationally accepted minimum standards for
recovery, default, and mortality rates. Time spent in the programme and rates of weight gain did
not meet these standards. Outpatient care could provide a complementary treatment strategy to
therapeutic feeding centres. Further research should compare the effectiveness of outpatient
and centre-based treatment of severe malnutrition in emergency nutritional interventions.
 Diop EI et al. “Home-based Rehabilitation for Severely Malnourished Children Using Locally
Made Ready-to-use Therapeutic Food (RUTF)” Reports from the 2nd World Congress of
Pediatric Gastroenterology, Hepatology and Nutrition. Paris (France), July 3-7, 2004.
Medimond, Monduzzi Editore (International Proceedings) pp. 101-105.
 Linneman Z. “A large-scale operational study of home-based therapy with ready-to-use
therapeutic food in childhood malnutrition in Malawi.” Matern Child Nutr (2007); 3: 206 –15.
Home-based therapy with ready-to-use therapeutic food (RUTF) for the treatment of
malnutrition has better outcomes in the research setting than standard therapy. This study
examined outcomes of malnourished children aged 6–60 months enrolled in operational homebased therapy with RUTF. Children enrolled in 12 rural centres in southern Malawi were
diagnosed with moderate or severe malnutrition according to the World Health Organization
guidelines. They were treated with 733 kJ kg−1 day−1 of RUTF and followed fortnightly for up to
8 weeks. Staff at each centre followed one of three models: medical professionals administered
treatment (5 centres), patients were referred by medical professionals and treated by
community health aids (4 centres), or community health aids administered treatment (3 centres).
The primary outcome of the study was clinical status, defined as recovered, failed, died or
dropped out. Regression modelling was conducted to determine what aspects of the centre
(formal training of staff, location along a main road) contributed to the outcome. Of 2131
severely malnourished children and 806 moderately malnourished, 89% and 85% recovered,
20
respectively. Thirty-four (4%) of the moderately malnourished children failed, with 20 (2%)
deaths, and 61 (3%) of the severely malnourished children failed, with 29 (1%) deaths. Centre
location along a road was associated with a poor outcome. Outcomes for severely malnourished
children were acceptable with respect to both the Sphere guidelines and the Prudhon case
fatality index. Home-based therapy with RUTF yields acceptable results without requiring
formally medically trained personnel; further implementation in comparable settings should be
considered.
 Manary MJ. “Home based therapy for severe malnutrition with ready-to-use food.” Arch Dis
Child. (2004); 89: 557-61.
Background: The standard treatment of severe malnutrition in Malawi often utilises prolonged
inpatient care, and after discharge results in high rates of relapse.
Objectives: To test the hypothesis that the recovery rate, defined as catch-up growth such that
weight-for-height z score >0 (WHZ, based on initial height) for ready-to-use food (RUTF) is
greater than two other home based dietary regimens in the treatment of malnutrition.
Methods: HIV negative children >1 year old discharged from the nutrition unit in Blantyre,
Malawi were systematically allocated to one of three dietary regimens: RUTF, RUTF supplement,
or blended maize/soy flour. RUTF and maize/soy flour provided 730 kJ/kg/day, while the RUTF
supplement provided a fixed amount of energy, 2100 kJ/day. Children were followed fortnightly.
Children completed the study when they reached WHZ >0, relapsed, or died. Outcomes were
compared using a time-event model.
Results: A total of 282 children were enrolled. Children receiving RUTF were more likely to reach
WHZ >0 than those receiving RUTF supplement or maize/soy flour (95% v 78%, RR 1.2, 95% CI 1.1
to 1.3). The average weight gain was 5.2 g/kg/day in the RUTF group compared to 3.1 g/kg/day
for the maize/soy and RUTF supplement groups. Six months later, 96% of all children that
reached WHZ >0 were not wasted.
Conclusions: Home based therapy of malnutrition with RUTF was successful; further operational
work is needed to implement this promising therapy.
 Manary M et al. “Randomized, Double-Blind Controlled Clinical Effectiveness Trial Comparing a
Novel 10% Milk Ready-to-Use Therapeutic Food with the Standard 25% Milk Ready-to-Use
Therapeutic Food in the Treatment of Severe Acute Malnutrition in Rural Malawian Children.”
(2009) Washington, DC: FANTA-2, Academy for Educational Development.
Severe childhood malnutrition is defined as having a weight for height Z-score (WHZ) < -3 or
bilateral pitting oedema. Standard therapy for cases of severe acute malnutrition without
complications is home-based therapy with milk-peanut based RUTF. The cost of ingredients in
RUTF limits its availability in resource-poor countries, with powdered milk constituting 67
percent of the cost. In this clinical effectiveness trial, severely malnourished children were given
either a reduced milk formulation of RUTF (10 percent milk) in which milk was replaced with soy
protein, or the standard formulation of RUTF (25 percent milk). Children received isocaloric
quantities of the foods (733 kJ/kg/d) for up to eight weeks with biweekly follow up. The primary
outcome was recovery, defined as having a WHZ of -2 and no oedema. A total of 1874 children
were enrolled in the study. Children receiving 10 percent milk had a lower rate of recovery
compared to those receiving the standard therapy (84 percent in the 25 percent milk group and
81 percent in the 10 percent milk group). Nonlinear regression modeling showed type of food to
be a statistically significant term in rate of recovery. Overall, children who received the 10
percent milk formulation had slower rates of weight gain and slower MUAC gain. Differences of
gain in stature were not statistically significant. Treating severely malnourished children with a
10 percent milk RUTF results in a lower rate of recovery and slower growth rates when compared
to the standard 25 percent milk RUTF.
21
 Navarro-Colorado C and McKenney P. “Home Based Rehabilitation of Severe Malnutrition vs.
Inpatient care in a post-emergency setting. A Randomised Clinical Trial in Sierra Leone.” Draft
Report.

Oakley E et al. “A ready-to-use therapeutic food containing 10% milk is less
effective than one with 25% milk in the treatment of severely malnourished children.” J
Nutr. (2010); 140: 2248-52.
Standard therapy for severe acute malnutrition (SAM) is home-based therapy with ready-to-use
therapeutic food (RUTF) containing 25% milk. In an effort to lower the cost of RUTF and increase
availability, some have suggested that a portion of milk be replaced with soy. This trial was
designed to determine whether treating children with SAM with 10% milk RUTF containing soy
would result in a similar recovery rate compared with the 25% milk RUTF. This was a randomized,
double-blind, controlled, clinical, quasi-effectiveness trial of isoenergetic amounts of 2 locally
produced RUTF to treat SAM in Malawi among children aged 6–59 mo. A total of 1874 children
were enrolled. Children were assessed every fortnight and participated in the study until they
clinically recovered or received 8 wk of treatment. The primary outcome was recovery (weightfor-height Z score > −2 and no edema). Secondary outcomes were rates of weight and height
gain. Survival analysis was used to compare the recovery rates. Recovery among children
receiving 25% milk RUTF was greater than children receiving 10% milk RUTF, 64% compared with
57% after 4 wk, and 84% compared with 81% after 8 wk (P < 0.001). Children receiving 25% milk
RUTF also had higher rates of weight and height gain compared with children receiving 10% milk
RUTF. Treating children with SAM with 10% milk RUTF is less effective compared with treatment
with the standard 25% milk RUTF. These findings also emphasize that clinical evidence should be
examined before recommending any changes to the formulation of RUTF.
 Sandige H et al. “Home-based treatment of malnourished Malawian children with locally
produced or imported ready-to-use food.” J Pediatr Gastroenterol Nutr. (2004); 39: 141-6.
Objectives: To determine the efficacy of home-based therapy with ready-to-use food (RTUF) in
producing catch-up growth in malnourished children and to compare locally produced RTUF with
imported RTUF for this purpose.
Methods: After a brief inpatient stabilization, 260 children with severe malnutrition were
enrolled and systematically allocated to receive home therapy with either imported,
commercially produced RTUF or locally produced RTUF. Each child received 730 kJ/kg/day and
was followed up fortnightly. Children completed the study when they reached a weight-forheight Z score > -0.5 (WHZ), relapsed, died, or failed to achieve WHZ > -0.5 after 16 weeks.
Analyses were stratified by human immunodeficiency virus (HIV) status.
Results: 78% of all children reached WHZ > -0.5, 95% of those with HIV-negative status and 59%
of those with HIV-positive status. Eighty percent of those receiving locally produced RTUF and
75% of those receiving imported RUTF reached WHZ > -0.5. The difference between recovery
rates was 5% (95% confidence interval [CI], -5-15%). The rate of weight gain was 0.4 g/kg/day
(95% CI, -0.6, 1.4) greater among children receiving locally produced RTUF. The prevalence of
diarrhea reported by mothers was 3.7% for locally produced RTUF and 4.3% for imported RTUF.
After completion of home therapy and resumption of habitual diet for 6 months, 91% of all
children maintained a normal WHZ.
Conclusions: Home-based therapy with RTUF was successful in affecting complete catch-up
growth. In this study, locally produced and imported RTUF were similar in efficacy in treating of
severe childhood malnutrition.
22
 Tectonidis M. “Crisis in Niger - Outpatient Care for Severe Acute Malnutrition.” N Engl J
Med. (2006); 354:224-7.
Available at: http://www.nejm.org/doi/full/10.1056/NEJMp058240
HIV-positive children
 Sunguya BF et al. “Ready To Use Therapeutic Food (RUTF) improves undernutrition among
ART-treated, HIV-positive children in Dar es Salaam, Tanzania.” Nut J. (2012); 11:60.
Available at: http://www.nutritionj.com/content/11/1/60
Background:
HIV/AIDS is associated with an increased burden of undernutrition among children even under
antiretroviral therapy (ART). To treat undernutrition, WHO endorsed the use of Ready to Use
Therapeutic Foods (RUTF) that can reduce case fatality and undernutrition among ART-naïve HIVpositive children. However, its effects are not studied among ART-treated, HIV-positive children.
Therefore, we examined the association between RUTF use with underweight, wasting, and
stunting statuses among ART-treated HIV-positive children in Dar es Salaam, Tanzania.
Methods:
This cross-sectional study was conducted from September-October 2010. The target population
was 219 ART-treated, HIV-positive children and the same number of their caregivers. We used
questionnaires to measure socio-economic factors, food security, RUTFuse, and ART-duration.
Our outcome variables were underweight, wasting, and stunting statuses.
Results:
Of 219 ART-treated, HIV-positive children, 140 (63.9%) had received RUTF intervention prior to
the interview. The percentages of underweight and wasting among non-RUTFreceivers were
12.4% and 16.5%; whereas those of RUTF-receivers were 3.0% (P = 0.006) and 2.8% (P = 0.001),
respectively. RUTF-receivers were less likely to have underweight (Adjusted Odd Ratio (AOR)
=0.19, CI: 0.04, 0.78), and wasting (AOR = 0.24, CI: 0.07, 0.81), compared to non RUTF-receivers.
Among RUTF receivers, children treated for at least four months (n = 84) were less likely to have
underweight (P = 0.049), wasting (P = 0.049) and stunting (P < 0.001).
Conclusions:
Among HIV-positive children under ART, the provision of RUTF for at least four months was
associated with low proportions of undernutrition status. RUTF has a potential to improve
undernutrition among HIV-positive children under ART in the clinical settings in Dar es Salaam,
Tanzania.
 Ndekha MJ. “Home-based therapy with ready-to-use therapeutic food is of benefit to
malnourished, HIV-infected Malawian children.” Acta Paed (2005); 93: 1-4.
Objective: To determine if home-based nutritional therapy will benefit a significant fraction of
malnourished, HIV-infected Malawian children, and to determine if ready-to-use therapeutic
food (RUTF) is more effective in home-based nutritional therapy than traditional foods.
Methods: 93 HIV-positive children >1 y old discharged from the nutrition unit in Blantyre, Malawi
were systematically allocated to one of three dietary regimens: RUTF, RUTF supplement or
blended maize/soy flour. RUTF and maize/soy flour provided 730 kJ x kg(-1) x d(-1), while the
RUTF supplement provided a fixed amount of energy, 2100 kJ/d. These children did not receive
antiretroviral chemotherapy. Children were followed fortnightly. Children completed the study
when they reached 100% weight-for-height, relapsed or died. Outcomes were compared using
regression modeling to account for differences in the severity of malnutrition between the
dietary groups.
23
Results: 52/93 (56%) of all children reached 100% weight-for-height. Regression modeling found
that the children receiving RUTF gained weight more rapidly and were more likely to reach 100%
weight-for-height than the other two dietary groups (p < 0.05).
Conclusion: More than half of malnourished, HIV-infected children not receiving antiretroviral
chemotherapy benefit from home-based nutritional rehabilitation. Home-based therapy RUTF is
associated with more rapid weight gain and a higher likelihood of reaching 100% weight-forheight.
 Bahwere P et al. “Uptake of HIV testing and outcomes within a Community-based Therapeutic
Care (CTC) programme to treat Severe Acute Malnutrition in Malawi: a descriptive study.” BMC
Infect Dis. (2008); 8: 106.
Background: In Malawi and other high HIV prevalence countries, studies suggest that more than
30% of all severely malnourished children admitted to inpatient nutrition rehabilitation units are
HIV-infected. However, clinical algorithms designed to diagnose paediatric HIV are neither
sensitive nor specific in severely malnourished children.
Objectives: The present study was conducted to assess : i) whether HIV testing can be integrated
into Community-based Therapeutic Care (CTC); ii) to determine if CTC can improve the
identification of HIV infected children; and iii) to assess the impact of CTC programmes on the
rehabilitation of HIV-infected children with Severe Acute Malnutrition (SAM).
Methods: This community-based cohort study was conducted in Dowa District, Central Malawi, a
rural area 50 km from the capital, Lilongwe. Caregivers and children admitted in the Dowa CTC
programme were prospectively (Prospective Cohort = PC) and retrospectively (Retrospective
Cohort = RC) admitted into the study and offered HIV testing and counseling. Basic medical care
and community nutrition rehabilitation was provided for children with SAM. The outcomes of
interest were uptake of HIV testing, and recovery, relapse, and growth rates of HIV-positive and
uninfected children in the CTC programme. Student's t-test and analysis of variance were used to
compare means and Kruskall Wallis tests were used to compare medians. Dichotomous variables
were compared using Chi2 analyses and Fisher's exact test. Stepwise logistic regression with
backward elimination was used to identify predictors of HIV infection (alpha = 0.05).
Results: 1273 and 735 children were enrolled in the RC and PC. For the RC, the average age (SD)
at CTC admission was 30.0 (17.2) months. For the PC, the average age at admission was 26.5
(13.7) months. Overall uptake of HIV testing was 60.7% for parents and 94% for children. HIV
prevalence in severely malnourished children was 3%, much lower than anticipated. 59% of HIVpositive and 83% of HIV-negative children achieved discharge Weight-For-Height (WFH) > or =
80% of the NCHS reference median (p = 0.003). Clinical algorithms for diagnosing HIV in SAM
children had poor sensitivity and specificity.
Conclusion: CTC is a potentially valuable entry point for providing HIV testing and care in the
community to HIV infected children with SAM.
HIV-positive adults

Ndekha MJ et al. “Supplementary feeding with either ready-to-use fortified spread
or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised,
investigator blinded, controlled trial.” BMJ. (2009); 338: b1867.
Objective: To investigate the effect of two different food supplements on body mass index
(BMI) in wasted Malawian adults with HIV who were starting antiretroviral therapy.
Results: The mean BMI at enrolment was 16.5. After 14 weeks, patients receiving fortified
spread had a greater increase in BMI and fat-free body mass than those receiving corn-soy
blend: 2.2 (SD 1.9) v 1.7 (SD 1.6) (difference 0.5, 95% confidence interval 0.2 to 0.8), and 2.9 (SD
24
3.2) v 2.2 (SD 3.0) kg (difference 0.7 kg, 0.2 to 1.2 kg), respectively. The mortality rate was 27%
for those receiving fortified spread and 26% for those receiving corn-soy blend. No significant
differences in the CD4 count, HIV viral load, assessment of quality of life, or adherence to
antiretroviral therapy were noted between the two groups.
Conclusion: Supplementary feeding with fortified spread resulted in a greater increase in BMI
and lean body mass than feeding with corn-soy blend.
 Ahoua L et al. “Nutrition outcomes of HIV-infected malnourished adults treated with ready-touse therapeutic food in sub-Saharan Africa: a longitudinal study.” J Int AIDS Soc. (2011); 14:2.
Background: Among people living with HIV/AIDS, nutritional support is increasingly recognized as
a critical part of the essential package of care, especially for patients in sub-Saharan Africa. The
objectives of the study were to evaluate the outcomes of HIV-positive malnourished adults
treated with ready-to-use therapeutic food and to identify factors associated with nutrition
programme failure.
Methods: We present results from a retrospective cohort analysis of patients aged 15 years or
older with a body mass index of less than 17 kg/m 2 enrolled in three HIV/AIDS care programmes
in Africa between March 2006 and August 2008. Factors associated with nutrition programme
failure (patients discharged uncured after six or more months of nutritional care, defaulting from
nutritional care, remaining in nutritional care for six or more months, or dead) were investigated
using multiple logistic regression.
Results: Overall, 1340 of 8685 (15.4%) HIV-positive adults were enrolled in the nutrition
programme. At admission, median body mass index was 15.8 kg/m 2 (IQR 14.9-16.4) and 12%
received combination antiretroviral therapy (ART). After a median of four months of follow up
(IQR 2.2-6.1), 524 of 1106 (47.4%) patients were considered cured. An overall total of 531 of
1106 (48.0%) patients failed nutrition therapy, 132 (11.9%) of whom died and 250 (22.6%)
defaulted from care. Men (OR = 1.5, 95% CI 1.2-2.0), patients with severe malnutrition at
nutrition programme enrolment (OR = 2.2, 95% CI 1.7-2.8), and those never started on ART (OR =
4.5, 95% CI 2.7-7.7 for those eligible; OR = 1.6, 95% CI 1.0-2.5 for those ineligible for ART at
enrolment) were at increased risk of nutrition programme failure. Diagnosed tuberculosis at
nutrition programme admission or during follow up, and presence of diarrhoeal disease or
extensive candidiasis at admission, were unrelated to nutrition programme failure.
Conclusions: Concomitant administration of ART and ready-to-use therapeutic food increases the
chances of nutritional recovery in these high-risk patients. While adequate nutrition is necessary
to treat malnourished HIV patients, development of improved strategies for the management of
severely malnourished patients with HIV/AIDS are urgently needed.
Effectiveness of Plumpy’Nut and Plumpy'Doz in the prevention of Acute Malnutrition in
children
 Isanaka S et al. « Reducing Wasting in Young Children with Preventive Supplementation: A
Cohort Study in Niger.” Pediatrics. (2010); 126: e442-50
Objectives: To compare the incidence of wasting, stunting, and mortality among children aged 6
to 36 months who are receiving preventive supplementation with either ready-to-use
supplementary foods (RUSFs) or ready-to-use therapeutic foods (RUTFs).
Methods: Children aged 6 to 36 months in 12 villages of Maradi, Niger, (n _ 1645) received a
monthly distribution of RUSFs (247 kcal [3 spoons] per day) for 6 months or RUTFs (500-kcal
sachet per day) for 4 months. We compared the incidence of wasting, stunting, and mortality
among children who received preventive supplementation with RUSFs versus RUTFs.
25
Results: The effectiveness of RUSF supplementation depended on receipt of a previous
preventive intervention. In villages in which a preventive supplementation program was
previously implemented, the RUSF strategy was associated with a 46% (95% confidence interval
[CI]: 6%–69%) and 59% (95% CI: 17%–80%) reduction in wasting and severe wasting, respectively.
In contrast, in villages in which the previous intervention was not implemented, we found no
difference in the incidence of wasting or severe wasting according to type of supplementation.
Compared with the RUTF strategy, the RUSF strategy was associated with a 19% (95% CI: 0%–
34%) reduction in stunting overall.
Conclusions: We found that the relative performance of a 6-month RUSF supplementation
strategy versus a 4-month RUTF strategy varied with receipt of a previous nutritional
intervention. Contextual factors will continue to be important in determining the dose and
duration of supplementation that will be most effective, acceptable, and sustainable for a given
setting.
Treatment of Moderate Acute Malnutrition in children
 Matilsky DK et al. “Supplementary feeding with fortified spreads results in higher recovery
rates than with corn/soy blend in moderately wasted children.” J Nutr. (2009); 139: 773–778.
Moderate childhood wasting is defined as having a weight-for-height Z-score (WHZ) < −2, but ≥
−3. These children are typically given fortified corn/soy blended flour (CSB), but this intervention
has shown limited effectiveness. Fortified spreads (FS) can be used as supplementary foods
instead; they are energy-dense, lipid-based pastes with added powdered micronutrients. In this
randomized clinical effectiveness trial, the recovery rates were compared among children with
moderate wasting who received either milk/peanut FS, soy/peanut FS, or CSB. Children received
isoenergetic quantities of food, 314 kJ·kg −1·d−1, for up to 8 wk with biweekly follow-up. The
primary outcome was recovery, defined as having a WHZ > −2. Time-event analysis was used to
compare the recovery rate. A total of 1362 children were enrolled in the study. Children receiving
soy/peanut FS had a similar recovery rate to those receiving milk/peanut FS and children in
either FS group were more likely to recover than those receiving CSB (80% in both FS groups vs.
72% in the CSB group; P < 0.01). The rate of weight gain in the first 2 wk was greater among
children receiving milk/peanut FS (2.6 g·kg −1·d−1, n = 465) or children receiving soy/peanut FS (2.4
g·kg−1·d−1, n = 450) than among children receiving CSB (2.0 g·kg −1·d−1, n = 447; P < 0.05). Rates of
length gain did not differ among the 3 groups. A total of 8% of children in each feeding group
developed edema, indicative of severe malnutrition, while receiving supplemental feeding. We
conclude that FS are superior supplementary foods to CSB for moderately wasted Malawian
children.
 Nackers F et al. “Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blendbased pre-mix for the treatment of childhood moderate acute malnutrition in Niger.” J Trop
Pediatr. (2010); 56: 407-13.
Standard nutritional treatment of moderate acute malnutrition (MAM) relies on fortified blended
flours though their importance to treat this condition is a matter of discussion. With the newly
introduced World Health Organization growth standards, more children at an early stage of
malnutrition will be treated following the dietary protocols as for severe acute malnutrition,
including ready-to-use therapeutic food (RUTF). We compared the effectiveness of RUTF and a
corn/soy-blend (CSB)-based pre-mix for the treatment of MAM in the supplementary feeding
programmes (SFPs) supported by Médecins Sans Frontières, located in the Zinder region (south
of Niger). Children measuring 65 to <110 cm, newly admitted with MAM [weight-for-height
(WHM%) between 70% and <80% of the NCHS median] were randomly allocated to receive
26
either RUTF (Plumpy’Nut, 1000 kcal day −1) or a CSB pre-mix (1231 kcal day −1). Other interventions
were similar in both groups (e.g. weekly family ration and ration at discharge). Children were
followed weekly up to recovery (WHM% ≥ 85% for 2 consecutive weeks). In total, 215 children
were recruited in the RUTF group and 236 children in the CSB pre-mix group with an overall
recovery rate of 79.1 and 64.4%, respectively (p < 0.001). There was no evidence for a difference
between death, defaulter and non-responder rates. More transfers to the inpatient Therapeutic
Feeding Centre (I-TFC) were observed in the CSB pre-mix group (19.1%) compared to the RUTF
group (9.3%) (p = 0.003). The average weight gain up to discharge was 1.08 g kg −1 day−1 higher in
the RUTF group [95% confidence interval: 0.46–1.70] and the length of stay was 2 weeks shorter
in the RUTF group (p < 0.001). For the treatment of childhood MAM in Niger, RUTF resulted in a
higher weight gain, a higher recovery rate, a shorter length of stay and a lower transfer rate to
the I-TFC compared to a CSB pre-mix. This might have important implications on the efficacy and
the quality of SFPs.
6.2
Where Plumpy’Nut has been distributed
 Briend A and Collins S. “Therapeutic Nutrition for Children with Severe Acute Malnutrition:
Summary of African Experience.” Indian Pediatr. (2010); 47: 655-659
Across Africa, Severe Acute Malnutrition (SAM) affects approximately 3% of children under five
at any time and is associated with several hundred thousand child deaths each year. Since the
1950s, efforts to treat these children as inpatients in hospitals or clinics have failed to lower
mortality rates and have achieved very poor coverage. During the past 10 years new communitybased management approaches treating over 85% of SAM cases solely as outpatients using
nutrient dense, lipid-based Ready to Use Therapeutic Foods have dramatically reduced mortality
and increased coverage rates. In 2005, this new model was endorsed by the UN under the name
Community-based Management of Acute Malnutrition (CMAM) and has now been adopted by
over 25 National governments and all major relief agencies. By 2009, approximately 1 million
cases of SAM were being treated annually, with programs expanding by approximately 30% year
on year.
 Community based approaches to managing severe malnutrition. ENN Report on the Proceeding
of an Inter-Agency workshop, Dublin, 8th-10th October 2003.
Available at: http://www.fantaproject.org/ctc/CTCreportlow.pdf
 Khara T and Collins S. “Community-Therapeutic Care (CTC).” ENN Special Supplement Series,
No.
2,
November
2004.
Available
at:
http://www.fantaproject.org/downloads/pdfs/ENNctc04.pdf
 Collins S. “Community-based therapeutic care - A new paradigm for selective feeding in
nutritional crises.” Humanitarian Practice Network. Network paper No 28. November 2004.
Available online.
6.3
Related references
 ACC/SCN “Working group on nutrition in emergencies.” Field Exchange (August 2001); Issue:
13:13.
 Achour L et al. “Comparison of gastric emptying of a solid and a liquid nutritional
rehabilitation food.” Eur J Clin Nutr (2001); 55: 769-772.
27











 Alam NH et al. “Efficacy and safety of a modified oral rehydration solution (resoMaL) in the
treatment of severely malnourished children with watery diarrhea.” J. Pediatr. (2003); 143: 614–
619.
 Amadi B et al. “Reduced production of sulphated glycosaminoglycans occurs in Zambian
children with kwashiorkor but not marasmus.” Am. J. Clin.Nutr. (2009); 89: 592–600.
 Amthor RE et al. “The use of home-based therapy with ready-to-use therapeutic food to treat
malnutrition in a rural area during a food crisis.” J Am Diet Assoc. (2009); 109: 464-7.
 Ashworth A et al. “Calorie requirements of children recovering from protein-calorie
malnutrition.” Lancet. (1968); 2:600–603.
 Ashworth A and Khanum S. “Cost-effective treatment for severely malnourished children:
what is the best approach?” Health Policy Plan (1997); 12:115-21
Black RE et al. “Maternal and child undernutrition and overweight in low-income and middleincome countries.” Lancet. (2013); 382:427-51.
Briend A et al. “Ready-to-Use Therapeutic Food for treatment of marasmus.” The Lancet. (1999);
353: 1767-8.
Briend A et al. “Putting the management of severe malnutrition back on the international
agenda.” Food Nutr. Bull. (2006); 27 (Suppl. 3).
Briend A. “Highly nutrient-dense spreads: a new approach to delivering multiple micronutrients
to high-risks groups.” Brit J Nutr (2001); 85: S175-S179.
Brown KH et al. “Effects of dietary energy density and feeding frequency on total daily energy
intakes of recovering malnourished children.” Am J Clin Nutr. (1995);62:13-8.
Collins S et al. “Key issues in the success of community-based management of severe
malnutrition.” Food Nutr. Bull. (2006); 27 (Suppl. 3), s49–s82.
Collins S. “Ambulatory treatment of severe malnutrition.” Field Exchange (July 2003); No 19.
Collins S. “Changing the way we address malnutrition during famine.” Lancet (2001); 358:498 501.
Dutta P et al. “Double blind, randomised controlled clinical trial of hypo-osmolar oral rehydration
salt solution in dehydrating acute diarrhoea in severely malnourished (marasmic) children.” Arch.
Dis. Child. (2001); 84: 237–240.
 FAO. Human energy requirements: Report of a Joint FAO/WHO/UNU Expert Consultation.
Rome: Food and Agriculture Organisation. (2004)
 Fergusson P and Tomkins A. “HIV prevalence and mortality among children undergoing
treatment for severe acute malnutrition in sub-saharan Africa: a systematic review and metaanalysis.” Trans. R. Soc. Trop. Med. Hyg. (2009); 103:541–548.
Fjeld CR et al. “Home based therapy for severe malnutrition with ready-to-use food.” Am J Clin
Nutr. (1989); 50: 1266–1275.
Golden MH. “Evolution of Nutritional Management of Acute Malnutrition” Indian Paediatrics
(2010); 47:667-78
 Golden MH et al. “Report of meeting on supplementary feeding programmes with particular
reference to refugee population.” Eur J Clin Nutr (1995); 49: 137-145.
 Golden MH et al. “Treatment of severe child malnutrition in refugee camps.” Eur J Clin Nutr
(1993); 47: 750-754.
 Golden MH. “Proposed recommended Nutrient Densities for Moderately Malnourished
Children.” Food and Nutrition Bulletin (2009); 30:267-342.
Available at:
http://www.who.int/nutrition/publications/moderate_malnutrition/FNBv30n3_suppl_paper1.pd
f
 Greco L et al. “Effect of a low-cost food on the recovery and death rate of malnourished
children.” J Pediatr Gastroenterol Nutr. (2006); 43:512-7.
28






 Heikens GT et al. “Long-stay versus short-stay hospital treatment of children suffering from
severe protein-energy malnutrition.” Eur. J. Clin Nutr. (1994); 48: 873–882.
Hossain MI et al. “Impact of community-based follow-up care, with or without food
supplementation and/or psychosocial stimulation, on the recovery of severely underweight
Bangladeshi children: a randomized intervention trial.” Mal Med J. (2009); 21:140.
Human Vitamin and Mineral Requirements: Report of a joint FAO/WHO expert consultation,
Bangkok, Thailand. Rome: Food and Agriculture Organisation. (2002)
Karaolis N et al. WHO guidelines for severe malnutrition: are they feasible in rural African
hospitals? Arch Dis Child (2007); 92:198–204.
 Kauffman CA et al. “Fever and malnutrition: endogenous pyrogen/ interleukin-1 in
malnourished patients.” Am J Clin Nutr. (1986); 44: 449–452.
Khanum S et al. “Controlled trial of three approaches to the treatment of severe malnutrition.”
Lancet (1994); 344: 1728–1732.
Khara T and Collins S. “Community-Therapeutic Care (CTC).” ENN Special Supplement
( November 2004); Series, No. 2.
 Lopriore C et al. “Spread fortified with vitamins and minerals induces catch-up growth and
eradicates severe anaemia in stunted refugee children aged 3–6 y.” Am J Clin Nutr. (2004); 80:
973–981.
 Maleta K et al. “Supplementary feeding of underweight, stunted Malawian children with a
ready-to-use food”. J Pediatr Gastroenterol Nutr. (2004); 38: 152–158.
 Manary MJ and Brewster DR. “Potassium supplementation in kwashiorkor.” J Pediatr
Gastroenterol Nutr (1997); 24: 194–201.
 Myatt M and Duffield A. “Weight-for-height and MUAC for estimating the prevalence of
acute undernutrition?” [online] http://www.humanitarianreform.org/humanitarianreform/
Portals/1/cluster%20approach%20page/clusters
%20pages/Nutrition/Myatt_sAve_UK_MUAC_Nutrition_Cluster_Oct22_07_section1_2_Optimize
d.pdf (2007)
 Navarro-Colorado C et al. “Comparison of a liquid with a dry ready to use Therapeutic food
for the rehabilitation of severely malnourished adults during famines: a randomised clinical trial.”
Unpublished manuscript.
 Navarro-Colorado Cand Laquière S. “Use of Solid Ready-to-Use-Therapeutic-Food (BP100) Vs
F100 milk for Rehabilitation of Severe Malnutrition during emergencies: A Clinical Trial in Sierra
Leone.” ENN Field Exchange.(March 2005); Issue 24.
 Nestel P et al. “Complementary Food Supplements to achieve Micronutrient Adequacy for
infants and young children” J Pediatr Gastroenterol Nutr. (2003); 36:316-28.
 Pelletier DL et al. “The effects of malnutrition on child mortality in developing countries.“
Bull.World Health Organ. (1995); 73: 443–448.
 Prudhon C et al. “Proceedings of the WHO, UNiCeF, and SCN informal consultation on
community-based management of severe malnutrition in children.” Food Nutr. Bull. (2006);
27:99–s104.
 Sadler K. “Key issues in the success of community-based management of severe
malnutrition” Food Nutr Bull (2006); 27: S49-S82.
Schoonees A et al. “Ready-to-use therapeutic food for home-based treatment of severe acute
malnutrition in children from six months to five years of age.” Cochrane Database Syst Rev .
(2013)
 Schroeder DG and Brown KH. “Nutritional status as a predictor of child survival: summarizing
the association and quantifying its global impact.” Bull. World Health Organ.(1994); 72:569–579.
 UNICEF. State of the World’s Children 2009: Maternal and Newborn Health. (2009)
29
 WHO & UNICEF. WHO child growth standards and the identification of severe acute
malnutrition in infants and children. Available at:
http://www.who.int/nutrition/publications/severemalnutrition/9789241598163_eng.pdf
 WHO. “Management of severe malnutrition: a manual for physicians and other senior health
workers.” (1999)
 WHO. “Management of the Child with a Serious Infection or Severe Malnutrition. Guidelines
for Care at the First-referral Level in Developing Countries.” (2000)
 WHO. Updates on the management of severe acute malnutrition in infants and children.
(2013)
Available
at:
http://www.who.int/nutrition/publications/guidelines/updates_management_SAM_infantandch
ildren/en/index.html
WFP. “Improving corn-soy blend and other fortified blended foods, why and how.” (2008)
30
7
PRODUCTION
7.1
Global Production
Plumpy'Nut consolidated production
30 000 T
26 577 T
26 511 T
23 542 T
25 000 T
24 730 T
20 101 T
20 000 T
15 467 T
15 000 T
Edesia
13 654 T
PlumpyField
10 000 T
Nutriset
5 000 T
0T
2008
7.2
2009
2010
2011
2012
2013
End of
Nov 14
Local Production
From its creation, Nutriset has supported local production. In 2005, a local and global
network of producers bad been created: PlumpyField. Based on each producer’s
competencies and their national specificities, the network unites 11 entrepreneurs (NGO,
private companies, non-for-profits) who are manufacturing Plumpy’Nut in countries with a
high level of under-nutrition. These organizations, by purchasing raw materials locally, also
have a positive impact on agricultural and economic development.
31
Plumpy’Nut is available from the following PlumpyField partners:
32
Name
Tel / Fax number Contact
name
Tel: +227 20 74 37 10
STA (Société
+227 90 44 43 42
de
Transformation Fax: +227 20 74 37 11
Alimentaire)
Mr. Ismael Barmou
General Manager
E-mail
[email protected]
+251 116 519 909 Mr Belete Beyene,
Hilina Enriched Tel:
Mobile: +251 911 238 453 Director
Foods P.L.C.
[email protected]
Ms Hilina Belete,
Deputy General
Manager
Operations
[email protected]
EDESIA
Mrs Navyn Salem,
Executive Director
Mrs Maria
Kasparian, Director
of Operations
[email protected]
rg
Mr. Thierry Barday
General Manager
thierry.bardai@basan.
mg
Fax:
+251 114 421 252
Tel: +1.401.272.5521
Fax: +1.401.272.5526
mkasparian@edesiaglo
bal.org
JB / TANJAKA
FOOD
Tel: +261 20 22 223 73
Mob: +261 32 07 477 61
Fax: +261 20 22 280 64
NUTRIVITA
FOODS PVT.
LTD.
Tel.:
+91 9545 5033 71 Mr. Nilkamal Joshi,
Mobile: +91 9545 0261 61 General Manager
[email protected]
[email protected]
Tel:
+91 22 2687 3855 Mr. Akhil Jain
Mobile: +91 9920 3022 39 Production
[email protected]
Manager
[email protected]
Meds and Food Haiti: +509 2813 9004
for Kids (MFK) USA : +1 314 420 1634
SAMIL
Tel. : +249 9123 03866
Fax: +249 83 563515
INNOFASO
Tel: +226 68 24 20 10
Tel: +226 78 80 62 09
Mrs Patricia Wolff
Executive Director
Mr. Hisham Salih
Abdelrahman
Yagoub
General Manager
Ms. Virginie
Claeyssens
General Manager
Mr. Omar Coulibaly
Project coordinator
33
[email protected]
[email protected]
om
virginie.claeyssens@inn
ofaso.com
omar.coulibaly@innofaso
.com
8
FAQs
Why did we call it Plumpy’Nut?
When Plumpy’Nut was launched, Nutriset wanted to create a turning point in the care of
malnutrition with this ready-to-use product. To support this innovation, we wanted to create
also a change in the name and use meaningful words instead of number used before and
only understandable by few.
The product being initially designed for children, we were thus looking for a word from the
childish universe. The word “Plumpy” has been chosen in relation to the shape Nutriset
wanted to give to the children that would eat the product. “Nut” was naturally added to give
some information about the product’s content.
Even if the name was surprising at that moment, it is now adopted by all, from humanitarian
actors to final users.
Does Plumpy’Nut increase the child’s need for water?
Plumpy’Nut is not likely to increase the child’s need for water, but it is recommended to
make drinkable water available for the child while consuming Plumpy’Nut.
What about risks associated with peanut allergies?
Although limited epidemiological data exists on peanut allergies in developing countries,
peanut allergies seem to be rare in settings where peanut-based nutrition products are
distributed. Over the last ten years several million children have received peanut-based
nutrition products and no severe allergic reactions have been reported 17,18,19,20,21.
What are the impacts of the patent on the eco-system of Plumpy’Nut?
Since 2005, PlumpyField members supply Plumpy’Nut to their countries and others nearby
using the highest industry quality standards. The patent protects livelihoods by preventing
local markets from being flooded with sometimes fake competing products manufactured in
17Gupta RS et al. “The prevalence, severity, and distribution of childhood food allergy in the United States.” Pediatrics.
(2011);128:9-17.
18Yang Z. “Are peanut allergies a concern for using peanut-based formulated foods in developing countries? “Food Nutr
Bull. (2010); 31:S147-53.
19Thompson RL et al. “Peanut sensitisation and allergy: influence of early life exposure to peanuts.” Br J Nutr.
(2010);103:1278-86.
20Greer FE et al. “Effects of early nutritional interventions on the development of atopic disease in infants and children: the
role of maternal dietary restriction, breastfeeding, timing of introduction of complementary foods, and hydrolyzed
formulas.” Pediatrics. (2008); 121:183-91.
21Burks AW et al. “NIAID-sponsored 2010 guidelines for managing food allergy: applications in the pediatric population.”
Pediatrics. (2011); 128:955-65.
34
more developed countries. It also allows nascent companies sufficient time to become more
efficient and competitive with global suppliers.
The price of Plumpy’Nut and similar products (widely called RUTFs) has not been
augmented by the patent, it was demonstrated that prices from patented suppliers and not
patented supplier are the same. Patented suppliers can even be cheaper. The product’s
greatest cost comes from the commodities needed to make it.
The patent does not cause a global shortage of Plumpy’Nut. There are still millions of
severely malnourished children around the world who are not being reached by Plumpy’Nut
and this is mainly due to a limited number of programmes and associated funding to identify
and treat these children at a country level. In countries such as Ethiopia, where no
Plumpy’Nut patent has been registered but where the prevalence and incidence of SAM in
children under 5 is amongst the highest in the world, the majority of RUTF used by
communities has been and still is Plumpy’Nut.
Can Plumpy’Nut be used in case of HIV-AID patient?
WHO recommends the use of among malnourished children suffering from HIV/AIDS 22.
Several studies both on ARV-naïve and ARV-treated children have demonstrated the safety
and efficacy of Plumpy’Nut to overcome malnutrition23,24,25,26.
Concerning the nutritional support of adults with HIV-AIDS , Nutriset has created
Plumpy’Soy, which is more adapted to adult needs in terms of micronutrients.
Can Plumpy’Nut be used for ill patients in more developed countries?
Products developed by Nutriset aim to treat and/or prevent specific nutritional deficiencies
by for instance compensating for monotonous diets or inappropriate feeding of infants and
young children.
Acceptability and efficacy of our products are systematically evaluated through rigorous
scientific studies.
At present, no study using our products aimed at treating or preventing acute malnutrition
has been run in an occidental context.
22WHO. “Guidelines for an integrated approach to the nutritional care of HIV-infected children (6 months – 14 years).”
2009
23Ndekha MJ et al. “Home-based therapy with ready-to-use therapeutic food is of benefit to malnourished, HIV-infected
Malawian children.” Acta Paediatr. (2005);94:222-5.
24Fergusson P et al. “Nutritional recovery in HIV-infected and HIV-uninfected children with severe acute malnutrition.”
Arch Dis Child (2009); 94:512–516.
25Sunguya BF et al. “Ready to Use Therapeutic Foods (RUTF) improves undernutrition among ART-treated, HIV-positive
children in Dar es Salaam, Tanzania.” Nutr J. (2012); 11:60.
26Kim MH et al. “Prompt initiation of ART With therapeutic food is associated with improved outcomes in HIV-infected
Malawian children with malnutrition.” J Acquir Immune Defic Syndr. (2012); 59:173-6.
35
ACRONYMS AND ABREVIATIONS
ART
Anti-Retroviral Therapy
BMI
Body Mass Index
CMAM
Community-Based Management of Acute
CSB
Corn Soy blend
CTC
Community-Based Therapeutic Care
FANTA
Food and Nutrition Technical Assistance
FAO
Food and Agriculture Organization
F75
Therapeutic Milk, 75 kcal/100ml
F100
Therapeutic Milk, 100 kcal/100ml
GMO
Genetically Modified Organism
HIV/AIDS
Human Immunodeficiency Virus/Acquired
MAM
Moderate Acute Malnutrition
NCHS
National Centre for Health Statistics
RUSF
Ready to Use Supplementary Food
RUTF
Ready to Use Therapeutic Food
SAM
Severe Acute Malnutrition
SFP
Supplementary Feeding Program
TFC
Therapeutic Feeding Centre
UNU
United Nation University
WFH
Weight-For-Height
WHZ
Weight-For-Height z score
WHO
World Health Organization
36