NCT01593033已完成不适用
Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation 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
- 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 micronutrients (full RDA) and micronutrients + fish oil 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
- •Will not move in next 6 months
- •Caregiver willing to give intervention daily for 6 months
排除标准
- •Unable to drink 20 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
- •Caregiver refusal to participate and return for 3 and 6 month follow-ups
研究组 & 干预措施
Fish oil and Micronutrient Supplementation
Experimental
干预措施: Fish oil and Micronutrient Supplementation (Dietary Supplement)
Micronutrient Supplementation
Experimental
干预措施: Micronutrient Supplement (Dietary Supplement)
Placebo
Placebo Comparator
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: 3 months, 6 months
次要结局
- Changes in the expression of several fecal mRNAs(3 months, 6 months)
- Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested(3 months, 6 months)
- Change in height(3 month, 6 month)
研究者
研究点 (1)
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