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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,260
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pumpy'Sup
Lipid-based nutrient supplement
干预措施: Plumpy'Sup (Dietary Supplement)
SCSB
Processed, fortified, cereal-based food blend (SCSB for malnourished children)
干预措施: SCSB (Dietary Supplement)
Misola
Locally processed, fortified food blend (Misola)
干预措施: Misola (Dietary Supplement)
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.
干预措施: Local food supplement (Dietary Supplement)
结局指标
主要结局
Weight gain
时间窗: 3 months
Continuation in treatment
时间窗: 3 months
次要结局
- Micronutrient status(3 months)
- Body composition(3 months)