Management of Children With Moderate Acute Malnutrition in Mali

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.

Conditions

• Moderate Acute Malnutrition (MAM)

Interventions

DIETARY_SUPPLEMENT

Plumpy'Sup

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

DIETARY_SUPPLEMENT

Local food 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.

DIETARY_SUPPLEMENT

Misola

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

DIETARY_SUPPLEMENT

SCSB

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

Sponsors & Collaborators

• University of Bamako

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• UNICEF

  collaborator OTHER

• United Nations World Food Programme (WFP)

  collaborator OTHER

• Helen Keller International

  lead OTHER

Principal Investigators

• Kenneth H Brown, MD · Helen Keller International

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

35 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2011-08-31

Completion

2012-12-31

Countries

• Mali

Study Locations