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Management of Children With Moderate Acute Malnutrition in Mali (Mali-MMAM)

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ClinicalTrials.gov Identifier: NCT01015950
Recruitment Status : Unknown
Verified September 2011 by Helen Keller International.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2009
Last Update Posted : September 12, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Moderate Acute Malnutrition (MAM) Dietary Supplement: Plumpy'Sup Dietary Supplement: Local food supplement Dietary Supplement: Misola Dietary Supplement: SCSB

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pumpy'Sup
Lipid-based nutrient supplement
Dietary Supplement: Plumpy'Sup
Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d
Other Name: Plumpy'Sup, Supplementary Plumpy, Nutriset, France
Experimental: SCSB
Processed, fortified, cereal-based food blend (SCSB for malnourished children)
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
Other Name: World Food Program
Experimental: Misola
Locally processed, fortified food blend (Misola)
Dietary Supplement: Misola
Locally produced, millet-soy-peanut-based fortified complementary food (Misola)
Other Name: Misola, Mali
Active Comparator: Local food supplement
Local foods (millet flour, cowpea flour, sugar, oil) and a multiple micronutrient powder ("Mix-Me") are provided to simulate the currently recommended enhanced home-prepared rehabilitation food mixture ("farines enrchies") according to the national Mali CMAM protocol.
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.

Outcome Measures

Primary Outcome Measures :
  1. Weight gain [ Time Frame: 3 months ]
  2. Continuation in treatment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Micronutrient status [ Time Frame: 3 months ]
  2. Body composition [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015950

Helen Keller International
Bamako, Mali
Sponsors and Collaborators
Helen Keller International
University of Bamako
University of California, Davis
United Nations World Food Programme (WFP)
Principal Investigator: Kenneth H Brown, MD Helen Keller International
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helen Keller International
ClinicalTrials.gov Identifier: NCT01015950     History of Changes
Other Study ID Numbers: 200917501-1, 200917501-2
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Nutrition Disorders