This trial is active, not recruiting.

Condition moderate acute malnutrition (mam)
Treatments plumpy'sup, local food supplement, misola, scsb
Sponsor Helen Keller International
Collaborator University of Bamako
Start date May 2010
End date November 2011
Trial size 1260 participants
Trial identifier NCT01015950, 200917501-1, 200917501-2


The objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. The specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.), providing ~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children, providing ~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing ~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") for 12 weeks, as is currently recommended by the national CMAM protocol when special foods are not available.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Lipid-based nutrient supplement
plumpy'sup Plumpy'Sup, Supplementary Plumpy, Nutriset, France
Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d
Processed, fortified, cereal-based food blend (SCSB for malnourished children)
scsb World Food Program
Processed, fortified, corn-soy-milk-based food blend (SCSB for malnourished children, to be supplied by the World Food Program) to provide an additional 500 kcal/day
Locally processed, fortified food blend (Misola)
misola Misola, Mali
Locally produced, millet-soy-peanut-based fortified complementary food (Misola)
(Active Comparator)
Local foods (millet flour, cowpea flour, sugar, oil) and a multiple micronutrient powder ("Mix-Me") are provided to simulate the currently recommended enhanced home-prepared rehabilitation food mixture ("farines enrchies") according to the national Mali CMAM protocol.
local food supplement
Local foods (millet flour, cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") are provide, according to the national Mali CMAM protocol when special processed foods are not available.

Primary Outcomes

Weight gain
time frame: 3 months
Continuation in treatment
time frame: 3 months

Secondary Outcomes

Micronutrient status
time frame: 3 months
Body composition
time frame: 3 months

Eligibility Criteria

Male or female participants from 6 months up to 35 months old.

Inclusion Criteria: - age from 6 to 35 months, - MUAC <12.5 cm and >11.0 cm, and weight-for-length (WLZ) Z-score > -3.0 (WHO standard, 2006); or WLZ <-2.0 and >-3.0 and MUAC >11.0 cm - absence of bi-pedal edema - absence of current diseases requiring inpatient care - expected availability during the period of the study - residency within the study communities - acceptance of home visitors, and - written consent of a parent or guardian Exclusion Criteria: - age <6 months or >36 months - MUAC >12.5 cm and WLZ >-2.0; or MUAC <11.0 cm; or WLZ <-3.0 - presence of bi-pedal edema, - severe anemia (defined as hemoglobin <50 g/L), - other acute illnesses requiring inpatient treatment, - congenital abnormalities or underlying chronic diseases, including known HIV . infection, that may affect growth or risk of infection - history of allergy towards peanuts or previous serious allergic reaction to . any substance, requiring emergency medical care - concurrent participation in any other clinical trial

Additional Information

Official title Randomized, Community-Based Effectiveness Trial of Selected Dietary Strategies for the Management of Young Malian Children With Moderate Acute Malnutrition (MAM) in the Context of the National Community Management of Acute Malnutrition
Principal investigator Kenneth H Brown, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Helen Keller International.