Management of Children With Moderate Acute Malnutrition in Mali
NCT ID: NCT01015950
Last Updated: 2019-08-28
Study Results
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Basic Information
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COMPLETED
NA
1260 participants
INTERVENTIONAL
2010-05-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pumpy'Sup
Lipid-based nutrient supplement
Plumpy'Sup
Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d
SCSB
Processed, fortified, cereal-based food blend (SCSB for malnourished children)
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
Misola
Locally processed, fortified food blend (Misola)
Misola
Locally produced, millet-soy-peanut-based fortified complementary food (Misola)
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.
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.
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
35 Months
ALL
No
Sponsors
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University of Bamako
OTHER
University of California, Davis
OTHER
UNICEF
OTHER
United Nations World Food Programme (WFP)
OTHER
Helen Keller International
OTHER
Responsible Party
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Principal Investigators
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Kenneth H Brown, MD
Role: PRINCIPAL_INVESTIGATOR
Helen Keller International
Locations
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Helen Keller International
Bamako, , Mali
Countries
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References
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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.
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.
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.
Other Identifiers
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200917501-1, 200917501-2
Identifier Type: -
Identifier Source: org_study_id
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