Clinical trial NCT01015950: Management of Children With Moderate Acute Malnutrition in Mali
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
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Acute Malnutrition (MAM)
Lead sponsor: Helen Keller International
Sponsor class: OTHER
Collaborators: name: University of Bamako
name: University of California, Davis
name: UNICEF
name: United Nations World Food Programme (WFP)
First posted: 2009-11-18
Enrollment: 1260
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight gain
timeFrame: 3 months
measure: Continuation in treatment
timeFrame: 3 months
Secondary outcomes:
measure: Micronutrient status
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: Helen Keller International
Study officials:
affiliation: Helen Keller International
name: Kenneth H Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.