NCT01244204已完成不适用
Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia
Harvard School of Public Health (HSPH)0 个研究点目标入组 120 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Serum vitamin D levels
研究概览
简要总结
The investigators proposed a pilot study preparatory to developing a randomized trial of vitamin D for the prevention of TB infection. The specific aims are presented below:
- To recruit subjects, obtain consent, distribute vitamin D supplements to the children in the schools, obtain blood samples and transport them to the United States.
- To test the hypothesis that daily vitamin D supplementation will increase plasma levels of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages tested in vitro.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible subjects will be children age 12 to 15 years inclusive in public school, located in Songino-Khairhan district, who are residents of Ulaanbaatar, and whose parents have given informed consent and who accent to participate in the study.
排除标准
- •Individuals with pre-existing calcium, parathyroid conditions, or type I diabetes, sarcoidosis, or who require chronic diuretic therapy including calcium channel blockers, or who are cognitively impaired.
结局指标
主要结局
Serum vitamin D levels
时间窗: 6 months
Tuberculin Skin Test conversion
时间窗: 6 monhs
次要结局
未报告次要终点
研究者
Ganmaa Davaasambuu
Assistant Professor of Medicine
Harvard School of Public Health (HSPH)
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