临床试验/NCT01244204

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: 2012年8月3日

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

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

发起方

Harvard School of Public Health (HSPH)

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ganmaa Davaasambuu

Assistant Professor of Medicine

Harvard School of Public Health (HSPH)

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