A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Cell-mediated immunological markers
研究概览
简要总结
The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.
详细描述
In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active TB diagnosis by GeneXpert
- •HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay [ELISA] results)
排除标准
- •Children (<18 years of age)
- •60 years of age
- •Pregnant at baseline
- •Other severe complications or illnesses requiring hospitalization
- •Received TB treatment for greater than 4 weeks in the past 5 years
- •Refused to participate
- •Residing in a geographic location > 1 hour from AMC (by public transit)
结局指标
主要结局
Cell-mediated immunological markers
时间窗: One year
T cells
Vitamin D status
时间窗: One year
Serum 25(OH)D concentrations
Immune function
时间窗: One year
Immune responses will be assessed by the superoxide bursts and proteolytic capacities of macrophages and monocytes. Activity indexes will be assessed by comparing mean substrate and calibration fluorescence.
次要结局
- TB treatment outcomes(One year)
- HIV disease progression(One year)