NCT01395381撤回不适用
Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Benefit of Antihelminthic Therapy in the Community-Based Treatment of Severe Acute Malnutrition in Malawian Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- nutritional recovery
研究概览
简要总结
The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-59 months old
- •Kwashiorkor and/or Marasmus
- •Qualified for home-based therapeutic feeding with RUTF
排除标准
- •Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF
- •Unable to consume test-dose of RUTF in clinic
- •Parent refusal to participate and return for follow-up
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Albendazole
Experimental
干预措施: Albendazole (Drug)
结局指标
主要结局
nutritional recovery
时间窗: 12 weeks
Weight-for-Height Z-score (WHZ) \> -2 without bipedal pitting edema
mortality
时间窗: 12 weeks
次要结局
- malnutrition relapse(6 months)
- height and weight gain(6 months)
研究者
研究点 (1)
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