CTRI/2007/091/000008已完成3 期
A double blind, randomized, parallel, placebo control design study to determine the effect of addition of Vitamin D to conventional anti TB therapy
Christian Medical College,Vellore4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2009年1月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Time to sputum culture conversion
研究概览
简要总结
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 CMC DOTS centres ,TB clinic at Bethestha hospital,Ambur,Scudder memorial hospital,Ranipet,Adukambarai ,GH,TB clinics all around ,Velore. 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). Primary outcome is Time to sputum culture conversion at 8 weeks.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •1.Newly diagnosed smear positive pulmonary tuberculosis, including previously treated2.Age between 18 to 75 years3.No pre-existing liver or renal disease4.Consent given for HIV testing5.Available for return visits as outlined in the trial protocol
- •A firm Home address.
排除标准
- •1.Extra-pulmonary or smear negative tuberculosis 2.Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT 3.HIV infection4.Pregnant or lactating women
- •Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
- •6.Baseline Hypercalcemia (>10.5 mg/dl).
结局指标
主要结局
Time to sputum culture conversion
时间窗: 8 weeks
次要结局
- Proportion of patients culture positive(8 weeks)
- Performance status(8 weeks)
- TIme to sputum smear conversion(continuous)
- 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
研究点 (4)
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