Randomized controlled trial to study the efficacy of Vitamin D as an adjunctive treatment along with ATT on early sputum conversion in smear positive Pulmonary Tuberculosis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1) To compare the rate of sputum conversion between vitamin D supplementation group and control group
研究概览
简要总结
This study aims to evaluate “The efficacy of vitamin D as an adjunctive treatment along with ATT on early sputum conversion in smear positive pulmonary tuberculosisâ€. I am conducting this study under the guidance of Dr. Sandeep Soni, Professor & Head of department, Respiratory Medicine in Punjab Institute of Medical Sciences, Jalandhar, Punjab. This will be an open label randomized clinical study and there will be a minimum of 80 patients with smear positive Pulmonary Tuberculosis. They will be supplemented with oral doses of vitamin D3- 50,000 IU once a week for 8 weeks during the intensive phase and followed up every 14 days on day 0, 14, 28, 42, 56 with sputum smear examination, serum Vitamin D levels, Serum Calcium levels and clinical assessment. There is limited data on the efficacy of Vitamin D causing early sputum conversion in smear positive pulmonary tuberculosis and therefore this randomized clinical study aims to give evidence that would help in clinical practice and assist ongoing efforts at streamlining TB treatment.
This study addresses specific targets outlined in the END TB STRATEGY, such as decline in TB deaths, ending catastrophic costs for TB-affected households by 2035.
The study findings can contribute to achieving the milestones set by the End TB strategy, particularly in terms of reducing the burden of smear-positive pulmonary tuberculosis and improving treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Newly diagnosed microbiologically confirmed smear positive Pulmonary Tuberculosis with serum 25 hydroxy cholecalciferol levels less than 30 ng/ml.
排除标准
- •Patient’s refusal 2) Pregnancy or lactation 3) Miliary TB 4) MDR TB 5) Old treated pulmonary TB 6) Hypersensitivity to Vitamin D supplements 7) A history of hypercalcemia, sarcoidosis, nephrolithiasis, hyperparathyroidism, seizures or cancer in the past.
- •Serum calcium above 10.5 mg/ml.
- •Current use of cytotoxic or immunosuppressive drug.
结局指标
主要结局
1) To compare the rate of sputum conversion between vitamin D supplementation group and control group
时间窗: 1 year
次要结局
- 2) To evaluate the safety & tolerability profile of therapeutic dose of vitamin D in TB patients(6 months)
研究者
Dr Ayushi Singh
Punjab Institute of Medical Sciences
