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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Bamako
University of California, Davis
UNICEF
United Nations World Food Programme (WFP)
Information provided by (Responsible Party):
Helen Keller International
ClinicalTrials.gov Identifier:
NCT01015950
First received: November 17, 2009
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Moderate Acute Malnutrition (MAM)
 Dietary Supplement: Plumpy'Sup
Dietary Supplement: Local food supplement
Dietary Supplement: Misola
Dietary Supplement: SCSB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helen Keller International:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Continuation in treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Micronutrient status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1260
Study Start Date: May 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015950

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

No publications provided

Responsible Party: Helen Keller International
ClinicalTrials.gov Identifier: NCT01015950     History of Changes
Other Study ID Numbers: 200917501-1, 200917501-2
Study First Received: November 17, 2009
Last Updated: September 9, 2011
Health Authority: Mali: Ministry of Health

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 22, 2013