NCT01015950

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,260 (actual)
• Sponsor: Helen Keller International · Academic / Other
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-08-01
• Completion: 2012-12-01
• First posted: 2009-11-18
• Last updated: 2019-08-28

Locations

1 site across 1 country: Mali