Effect of vitamin D supplementation on tuberculosis treatment outcome among Newly Registered Drug-Sensitive Tuberculosis (DSTB) patients at public health facilities of Western India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Higher sputum smear conversion rates and improved overall treatment success rate.
研究概览
简要总结
Tuberculosis is still a significant public health issue in India. Vitamin D is recognized for its ability to maintain the body’s immune system and potentially help manage tuberculosis infection by boosting the body’s natural protection. The impact of oral vitamin D supplementation provided in addition to regular anti-tuberculosis treatment among newly diagnosed drug-sensitive TB patients in public health centre in Western India will be assessed in this study. These patients will be divided into two groups: one group will receive vitamin D supplements along with conventional treatment, and the second group will receive conventional treatment alone. The expected outcomes will be sputum smear conversion at two and six months, overall success of treatment, weight gain, improvement in clinical findings. Any side effects or adverse events will also be observed and documented. The research will track each patient for a maximum of six months to compare findings and present evidence on whether vitamin D can serve as an effective additional strategy in standard TB care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed drug-sensitive tuberculosis (DSTB) patients, pulmonary or extra-pulmonary, aged 18 years and above, willing to participate and provide written informed consent.
排除标准
- •Patients will be excluded if they have drug-resistant tuberculosis (MDR/XDR), are HIV-positive, have chronic kidney disease evidenced by elevated serum creatinine levels or have significant chronic liver disease.
- •Patients will also be excluded if they have known hypercalcemia, a history of vitamin D toxicity, granulomatous diseases such as sarcoidosis, primary hyperparathyroidism, or malignancies associated with hypercalcemia (e.g., lymphoma, multiple myeloma).
- •Individuals currently taking vitamin D supplements, those on digitalis (digoxin) therapy, pregnant or lactating women, and patients with a known hypersensitivity to vitamin D preparations will also be excluded from the study.
结局指标
主要结局
Higher sputum smear conversion rates and improved overall treatment success rate.
时间窗: Sputum smear microscopy will be performed at- 2 months and at 6 months, to assess conversion from smear-positive to smear-negative status.
次要结局
- Greater weight gain, improvement in other clinical symptoms, monitoring & recording of any adverse events.(Outcome parameters will be assessed at baseline prior to treatment initiation, at 4 weeks, 8 weeks & monthly thereafter at 12, 16, 20 & 24 weeks, including at the point of treatment completion at 6 months.)
研究者
Dr Dularikunwarba Zala
GMERS medical college, Gotri.