Management of Children With Moderate Acute Malnutrition in Mali

Helen Keller International1,260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,260

Conditions

Moderate Acute Malnutrition (MAM)

Interventions

Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d

Local food supplementDIETARY_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.

MisolaDIETARY_SUPPLEMENT

Locally produced, millet-soy-peanut-based fortified complementary food (Misola)

SCSBDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 Months

Medical Language ↔ Plain English

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

Locations (1)

Helen Keller International

Bamako, Mali

Outcomes

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

Data from ClinicalTrials.gov

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