To study clinical effects of vitamin D supplementation on AGE-RAGE anti-inflammatory pathway in pulmonary tuberculosis patients in tertiary care hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Since vitamin D possess antibacterial effect, therefore, it may reduces the inflammatory AGE-RAGE pathway and eventually, TNF-alpha in TB patients
研究概览
简要总结
The primary aim of the study is to evaluate the inflammation controlling effect of Vitamin D supplementation due to the antibacterial effect along with standard therapy in pulmonary TB patients via the AGE-RAGE pathway. The vitamin D deficient patients will be recruited and will be divided in to two groups, standard therapy and vitamin D along with standard therapy. Baseline level detection of different inflammatory molecules in the pathway will be analysed in both groups. When patients will become sputum negative, again different inflammatory molecules in the pathway will be analysed in both groups.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to both sex, i.e. male and females of 18 yrs and above age group
- •Patients willing to provide written informed consent
- •Patients diagnosed with TB (Sputum +, microbiologically diagnosed)
- •Patients with no other coronary heart disease and malignant tumors
- •Patients on first line therapy (sensitive patients).
排除标准
- •Patients with severe organ diseases or liver dysfunctions
- •Patients who are not willing to provide written informed consent
- •Patients with mental illnesses
- •Patients with history of allergy to the study drugs
- •Patients with human immuno deficiency virus, upper respiratory tract infection, any infectious disease conditions which is asymptomatic, Hepatitis B and C.
结局指标
主要结局
Since vitamin D possess antibacterial effect, therefore, it may reduces the inflammatory AGE-RAGE pathway and eventually, TNF-alpha in TB patients
时间窗: The effect of supplementation will be observed in nearly 3 months or when patients will become sputum negative
次要结局
- Not applicable(Not applicable)
研究者
Dr Savita Devi
Kalpana Chawla Govt. Medical College, Karnal