Management of Children With Moderate Acute Malnutrition in Mali

NCT01015950 | Completed

• 1 other identifier: 200917501-1, 200917501-2
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate Acute Malnutrition (MAM)

Outcome Measures

Primary Outcomes (2)

• Weight gain

  3 months

• Continuation in treatment

  3 months

Secondary Outcomes (2)

• Micronutrient status

  3 months

• Body composition

  3 months

Study Arms (4)

Pumpy'Sup

EXPERIMENTAL

Lipid-based nutrient supplement

Dietary Supplement: Plumpy'Sup

SCSB

EXPERIMENTAL

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

Dietary Supplement: SCSB

Misola

EXPERIMENTAL

Locally processed, fortified food blend (Misola)

Dietary Supplement: Misola

Local food supplement

ACTIVE COMPARATOR

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

Interventions

Plumpy'Sup DIETARY_SUPPLEMENT

Lipid-based (vegetable oil, peanut paste, soy protein-containing) fortified nutrient supplement to provide 500 kcal/d

Also known as: Plumpy'Sup, Supplementary Plumpy, Nutriset, France

Pumpy'Sup

Local food supplement DIETARY_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.

Local food supplement

Misola DIETARY_SUPPLEMENT

Locally produced, millet-soy-peanut-based fortified complementary food (Misola)

Also known as: Misola, Mali

Misola

SCSB DIETARY_SUPPLEMENT

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

Also known as: World Food Program

SCSB

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helen Keller International: lead
• University of Bamako: collaborator
• University of California, Davis: collaborator
• UNICEF: collaborator
• United Nations World Food Programme (WFP): collaborator

Study Sites (1)

Helen Keller International

Bamako, Mali

Location

Related Publications (3)

• 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.

  PMID: 31139441 DERIVED

• 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.

  PMID: 30968123 DERIVED

• 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.

  PMID: 25733649 DERIVED

Study Officials

• Kenneth H Brown, MD

  Helen Keller International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: May 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

MA (1)