Nutrition, Immunology and Epidemiology of Tuberculosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 876
- 试验地点
- 2
- 主要终点
- To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection.
研究概览
简要总结
The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1
详细描述
Tuberculosis (TB) remains the single most common infectious disease cause of mortality. We propose to examine the inter- relationships of nutrition, immunology, and epidemiology with respect to TB in Tanzania. Given that TB is so much linked with HIV immunologically, clinically, and epidemiologically, it is essential to examine how these relationships are modified by HIV infection. Published animal and human studies suggest that vitamin deficiency is associated with poor immune response in TB. By modulating immune function, nutritional supplements may be a useful adjunct to anti-TB drugs, and could lead to the development of shorter drug regimens. All patients will receive standard anti-TB therapy. Follow-up visits will occur every two weeks for the first 2 months and monthly thereafter till the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women, age 18 to 60 years inclusive
- •At least two positive sputum smears for tuberculosis
- •Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
- •Subjects who grant informed consent to participation
排除标准
- •Karnofsky score < 40%
- •Hemoglobin < 8.5 g/dl
- •Having had treatment for TB exceeding 4 weeks in the last 5 years
- •Pregnant women
结局指标
主要结局
To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection.
时间窗: Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.
次要结局
- To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters.(Rate of change of HIV viral load in HIV positive patients: 2, 5, 8, and 20 months; Absolute change in CD4 counts: 2, 5, 8, and 20 months; Weight change from baseline: 2, 8, and 20 months; Immunological parameters: 2, 8, and 20 months.)