Management of Children With Moderate Acute Malnutrition in Mali

Not Applicable

Completed

• Conditions: Moderate Acute Malnutrition (MAM)
• Interventions: Dietary Supplement: Misola; Dietary Supplement: Plumpy'Sup; Dietary Supplement: Local food supplement; Dietary Supplement: SCSB

• Registration Number: NCT01015950
• Lead Sponsor: Helen Keller International

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Study Start: 2010-05
• Primary Completion: 2011-08
• Study Completion: 2012-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misola	Misola	Locally processed, fortified food blend (Misola)
Pumpy'Sup	Plumpy'Sup	Lipid-based nutrient supplement
Local food supplement	Local food supplement	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.
SCSB	SCSB	Processed, fortified, cereal-based food blend (SCSB for malnourished children)

Primary Outcome Measures

Name	Time	Method
Weight gain	3 months
Continuation in treatment	3 months

Secondary Outcome Measures

Name	Time	Method
Micronutrient status	3 months
Body composition	3 months

Trial Locations

Locations (1)

Helen Keller International; 🇲🇱 Bamako, Mali