Management of Children With Moderate Acute Malnutrition in Mali (NCT01015950) | Clinical Trial Compass
CompletedNot Applicable
Management of Children With Moderate Acute Malnutrition in Mali
Mali1,260 participantsStarted 2010-05
Plain-language 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.
Who can participate
Age range
6 Months – 35 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.