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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015950

Acronym

Mali-MMAM

Enrollment

1260

Registered

2009-11-18

Start date

2010-05-31

Completion date

2012-12-31

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Acute Malnutrition (MAM)

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.

Interventions

DIETARY_SUPPLEMENTPlumpy'Sup

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

DIETARY_SUPPLEMENTLocal 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_SUPPLEMENTMisola

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

DIETARY_SUPPLEMENTSCSB

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 35 Months

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

Design outcomes

Primary

Measure	Time frame
Weight gain	3 months
Continuation in treatment	3 months

Secondary

Measure	Time frame
Micronutrient status	3 months
Body composition	3 months

Countries

Mali

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026