Management of Children With Moderate Acute Malnutrition in Mali

Moderate Acute Malnutrition (MAM) Clinical Trial

— Mali-MMAM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015950
• Other study ID #: 200917501-1, 200917501-2
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2019
• Source: Helen Keller International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1260
• Est. completion date: December 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Moderate Acute Malnutrition (MAM)

Intervention

Dietary Supplement:
• Plumpy'Sup
Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d
• 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.
• Misola
Locally produced, millet-soy-peanut-based fortified complementary food (Misola)
• 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

Locations

Country	Name	City	State
Mali	Helen Keller International	Bamako

Sponsors (5)

Lead Sponsor	Collaborator
Helen Keller International	UNICEF, United Nations World Food Programme (WFP), University of Bamako, University of California, Davis

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain		3 months
Primary	Continuation in treatment		3 months
Secondary	Micronutrient status		3 months
Secondary	Body composition		3 months