NCT00419068已完成3 期
Trial of Adjunctive Vitamin D in Tuberculosis Treatment
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 8
- 主要终点
- Time to sputum culture conversion
研究概览
简要总结
The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected smear positive pulmonary tuberculosis.
- •Age 18 years or older.
- •Written informed consent to participate.
排除标准
- •Known intolerance of vitamin D or first-line anti-tuberculous therapy.
- •Taking antituberculous therapy for more than six days in the six months preceding enrolment.
- •Taking the following medication in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy.
- •Taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol.
- •Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, HIV infection, liver failure, renal failure or malignancy
- •Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing)
- •Biochemical disturbance at enrolment: serum corrected calcium >2.66 mmol/l, serum AST >120 IU/l, total serum bilirubin > 40 micromol/l or serum creatinine > 250 micromol/l
- •Breastfeeding or pregnancy
结局指标
主要结局
Time to sputum culture conversion
次要结局
- Rate of bacillary kill
- 2-month culture conversion rate
- Time to sputum smear conversion
- Weight change
- Radiographic response
研究者
研究点 (8)
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