Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- weight gain
研究概览
简要总结
In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances, the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The main objective of this sub-study is to test the efficacy of the newly developed RUTF on the recovery of children suffering from severe acute malnutrition. As comparison, the current treatment of SAM with BP-100 will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •discharged from hospital after admission for SAM
- •WHZ <2.8 Z-score or MUAC<11.5 cm
- •no complications
- •passing the appetite test
排除标准
- •<6 mo of age
- •complications related to SAM
研究组 & 干预措施
BP-100
standard treatment
干预措施: 2 months of treatment (Dietary Supplement)
Num Trey
locally produced RUTF
干预措施: 2 months of treatment (Dietary Supplement)
结局指标
主要结局
weight gain
时间窗: 2 months
weight gain in g/kg/day
次要结局
- Fatty Acid composition(2 months)
- body composition(2 months)
研究者
Frank Wieringa
Senior Researcher
Institut de Recherche pour le Developpement