Management of Children With Moderate Acute Malnutrition in Mali

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Moderate Acute Malnutrition (MAM)

Intervention / Treatment
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* Dietary Supplement: Plumpy'Sup
* Dietary Supplement: Local food supplement
* Dietary Supplement: Misola
* Dietary Supplement: SCSB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pumpy'Sup<br>Lipid-based nutrient supplement | Dietary Supplement: Plumpy'Sup<br>* Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d<br>* Other names: Plumpy'Sup, Supplementary Plumpy, Nutriset, France;|
| Experimental: SCSB<br>Processed, fortified, cereal-based food blend (SCSB for malnourished children) | Dietary Supplement: SCSB<br>* 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<br>* Other names: World Food Program;|
| Experimental: Misola<br>Locally processed, fortified food blend (Misola) | Dietary Supplement: Misola<br>* Locally produced, millet-soy-peanut-based fortified complementary food (Misola)<br>* Other names: Misola, Mali;|
| Active Comparator: Local food supplement<br>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. | Dietary Supplement: Local food supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 3 months | 
| Continuation in treatment |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Micronutrient status |  | 3 months | 
| Body composition |  | 3 months |