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Completed

NCT Number: NCT01015950

Management of Children With Moderate Acute Malnutrition in Mali

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.

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Key information

Conditions

Moderate Acute Malnutrition (MAM)

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helen Keller International

Bamako, Mali

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plumpy'Sup

Dietary Supplement

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

Other names: Plumpy'Sup, Supplementary Plumpy, Nutriset, France

Local food supplement

Dietary 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.

Misola

Dietary Supplement

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

Other names: Misola, Mali

SCSB

Dietary 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

Other names: World Food Program

Primary outcomes

  1. Weight gain

    Time frame: 3 months

  2. Continuation in treatment

    Time frame: 3 months

Secondary outcomes

  1. Micronutrient status

    Time frame: 3 months

  2. Body composition

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Helen Keller International

Other

Collaborators

  • UNICEF
  • United Nations World Food Programme (WFP)
  • University of Bamako
  • University of California, Davis

Registry information

Official study title

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

Acronym: Mali-MMAM

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 18, 2009
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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