Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of High-dose Zinc Therapy and Albendazole in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
研究概览
简要总结
The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.
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
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1-3 years of age
- •Lives in study villages
排除标准
- •Unable to drink 100 mL of sugar water
- •Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
- •Apparent need for acute medical treatment for an illness or injury
- •Parent refusal to participate and return for 7-week follow-up
研究组 & 干预措施
Zinc therapy
High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days
干预措施: High-dose Zinc (Dietary Supplement)
Albendazole
Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.
干预措施: Albendazole (Drug)
Placebo
Placebo will be given for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
时间窗: 4 weeks, 7 weeks
次要结局
- Change in blood endoCAb(7 weeks)
- Change in fecal calprotectin mRNA(4 weeks, 7 weeks)