Management of Children With Moderate Acute Malnutrition in Mali (Mali-MMAM)

Helen Keller International

Status: Completed

Conditions: Moderate Acute Malnutrition (MAM)

Treatments: Dietary Supplement: Local food supplement; Dietary Supplement: Misola; Dietary Supplement: SCSB; Dietary Supplement: Plumpy'Sup

Study type: Interventional

Funder types: Other

Identifiers

NCT01015950

200917501-1, 200917501-2

Details and patient eligibility

About

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.

Enrollment: 1,260 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,260 participants in 4 patient groups

Pumpy'Sup

Experimental group

Description:

Lipid-based nutrient supplement

Treatment:

Dietary Supplement: Plumpy'Sup

SCSB

Experimental group

Description:

Processed, fortified, cereal-based food blend (SCSB for malnourished children)

Treatment:

Dietary Supplement: SCSB

Misola

Experimental group

Description:

Locally processed, fortified food blend (Misola)

Treatment:

Dietary Supplement: Misola

Local food supplement

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Local food supplement