A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Peter Daley
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Time to sputum culture conversion
研究概览
简要总结
There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).
详细描述
The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in TB patients treated with vitamin D in combination with standard DOTS therapy. It will take place in four South Indian DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a 1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed smear positive pulmonary tuberculosis.
- •Age between 18 to 75 years
- •No pre-existing liver or renal disease
- •Available for return visits as outlined in the trial protocol
- •A Firm home address
排除标准
- •Extra-pulmonary or smear negative tuberculosis
- •Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
- •Pregnant or lactating women
- •Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
- •Baseline Hypercalcemia >10.5 mg/dl
研究组 & 干预措施
A
Vitamin D in doses of 100,000 IU
干预措施: A. 100,000 IU Cholecalciferol per dose of 3.3ml (Drug)
B
干预措施: B. Migliol Oil without Cholecalciferol (Other)
结局指标
主要结局
Time to sputum culture conversion
时间窗: 8 weeks of treatment
次要结局
- Percent of Patients Culture Positive(8 Weeks)
- Performance Status(8 Weeks)
- Time To Sputum Smear Conversion(Continous)
- Proportion of Patients Smear Positive(4 Weeks, 8 Weeks, 12 Weeks)
- Time To Growth In Liquid Media(8 Weeks)
- RNTCP Treatment Outcomes(24 Weeks)
- Weight Gain(8 Weeks)
研究者
Peter Daley
Lecturer
Christian Medical College, Vellore, India