NCT02253095已完成不适用
Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Dual Sugar Absorption Test
研究概览
简要总结
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.
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
- 12 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children residing in catchment area of Limela, Machinga District, Malawi
- •aged 12-35 months
- •youngest eligible child in each household
排除标准
- •severe acute malnutrition
- •severe chronic illness
- •children unable to drink 20 mL of dual sugar solution
- •children in need of acute medical treatment for illness or injury at time of enrollment
研究组 & 干预措施
Multiple Intervention Arm
Experimental
single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
干预措施: Albendazole (Drug)
Multiple Intervention Arm
Experimental
single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
干预措施: Zinc (Dietary Supplement)
Multiple Intervention Arm
Experimental
single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
干预措施: Multiple Micronutrient Supplement (Dietary Supplement)
Placebo
Placebo Comparator
three placebos
干预措施: Placebo (Drug)
结局指标
主要结局
Dual Sugar Absorption Test
时间窗: 24 weeks
lactulose-mannitol ratio in urine
次要结局
- Lactulose Excretion(24 weeks)
- Mannitol Excretion(24 weeks)
研究者
研究点 (1)
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