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

Primary Purpose

Moderate Acute Malnutrition (MAM)

Status
Completed
Phase
Not Applicable
Locations
Mali
Study Type
Interventional
Intervention
Plumpy'Sup
Local food supplement
Misola
SCSB
Sponsored by
Helen Keller International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Acute Malnutrition (MAM)

Eligibility Criteria

6 Months - 35 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Helen Keller International

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Pumpy'Sup

SCSB

Misola

Local food supplement

Arm Description

Lipid-based nutrient supplement

Processed, fortified, cereal-based food blend (SCSB for malnourished children)

Locally processed, fortified food blend (Misola)

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.

Outcomes

Primary Outcome Measures

Weight gain
Continuation in treatment

Secondary Outcome Measures

Micronutrient status
Body composition

Full Information

First Posted
November 17, 2009
Last Updated
August 22, 2019
Sponsor
Helen Keller International
Collaborators
University of Bamako, University of California, Davis, UNICEF, United Nations World Food Programme (WFP)
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1. Study Identification

Unique Protocol Identification Number
NCT01015950
Brief Title
Management of Children With Moderate Acute Malnutrition in Mali
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helen Keller International
Collaborators
University of Bamako, University of California, Davis, UNICEF, United Nations World Food Programme (WFP)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Acute Malnutrition (MAM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pumpy'Sup
Arm Type
Experimental
Arm Description
Lipid-based nutrient supplement
Arm Title
SCSB
Arm Type
Experimental
Arm Description
Processed, fortified, cereal-based food blend (SCSB for malnourished children)
Arm Title
Misola
Arm Type
Experimental
Arm Description
Locally processed, fortified food blend (Misola)
Arm Title
Local food supplement
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Plumpy'Sup
Other Intervention Name(s)
Plumpy'Sup, Supplementary Plumpy, Nutriset, France
Intervention Description
Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Local food supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Misola
Other Intervention Name(s)
Misola, Mali
Intervention Description
Locally produced, millet-soy-peanut-based fortified complementary food (Misola)
Intervention Type
Dietary Supplement
Intervention Name(s)
SCSB
Other Intervention Name(s)
World Food Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
3 months
Title
Continuation in treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Micronutrient status
Time Frame
3 months
Title
Body composition
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth H Brown, MD
Organizational Affiliation
Helen Keller International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Keller International
City
Bamako
Country
Mali

12. IPD Sharing Statement

Citations:
PubMed Identifier
31139441
Citation
Isanaka S, Barnhart DA, McDonald CM, Ackatia-Armah RS, Kupka R, Doumbia S, Brown KH, Menzies NA. Cost-effectiveness of community-based screening and treatment of moderate acute malnutrition in Mali. BMJ Glob Health. 2019 Apr 28;4(2):e001227. doi: 10.1136/bmjgh-2018-001227. eCollection 2019.
Results Reference
derived
PubMed Identifier
30968123
Citation
McDonald CM, Ackatia-Armah RS, Doumbia S, Kupka R, Duggan CP, Brown KH. Percent Fat Mass Increases with Recovery, But Does Not Vary According to Dietary Therapy in Young Malian Children Treated for Moderate Acute Malnutrition. J Nutr. 2019 Jun 1;149(6):1089-1096. doi: 10.1093/jn/nxz037.
Results Reference
derived
PubMed Identifier
25733649
Citation
Ackatia-Armah RS, McDonald CM, Doumbia S, Erhardt JG, Hamer DH, Brown KH. Malian children with moderate acute malnutrition who are treated with lipid-based dietary supplements have greater weight gains and recovery rates than those treated with locally produced cereal-legume products: a community-based, cluster-randomized trial. Am J Clin Nutr. 2015 Mar;101(3):632-45. doi: 10.3945/ajcn.113.069807. Epub 2015 Jan 7.
Results Reference
derived

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Management of Children With Moderate Acute Malnutrition in Mali

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