Arginine Rich Food Supplementation as an Adjuvant Treatment Against Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Final outcome according to WHO
研究概览
简要总结
The purpose of this study was to investigate if adjuvant treatment with arginine (the substrate for nitric oxide production) rich food supplements could improve clinical outcome in patients with smear positive tuberculosis by affecting nitric oxide production.
详细描述
Tuberculosis (TB) is disease of increased global public health importance. Because of emerging multi drug resistance and the long treatment duration there is a need to optimize the current chemotherapy. Host immunity is important in determining the susceptibility and outcome of disease as could be exemplified by co infection with HIV which dramatically increases the risk to develop TB.
Previous results from our group and others show that nitric oxide produced by activated macrophages from arginine might be important to control the disease. However, the relative importance of nitric oxide in human TB has been debated. In a previous study in Gondar, Ethiopia, we observed an effect of adjuvant treatment with arginine capsules on sputum smear conversion and reduction of cough. In this study we wanted to test the hypothesis based on previous observations that an arginine rich food supplementation might enhance clinical improvement in patients with smear positive tuberculosis and if this effect could be due to increased nitric oxide production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed and written consent to take part in the study
- •Previously untreated and newly diagnosed smear positive Tb patients according to the WHO definitions
排除标准
- •Hospitalization
- •Pregnancy
- •Known allergy against peanuts
- •Chronic or acute disease other than tuberculosis/HIV
结局指标
主要结局
Final outcome according to WHO
时间窗: 8 months
次要结局
- Change in Chest X-ray pattern from baseline to 2 months(2 months)
- Weight gain from baseline until 2 months(2 months)
- Sedimentation rate(2 months)
- Reduction of cough from baseline to 2 months(1 and 2 months)
- Levels of exhaled and urinary nitric oxide(First week, week 2, week 8, and month 5)
- Sputum smear conversion(2 months)