Management of Children With Moderate Acute Malnutrition in Mali

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

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.

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