The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
We propose a randomised trial among pulmonary TB patients, examined and treated as part of the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in high TB and HIV burden countries. The overall objective of the proposed trial is to assess the effect of nutritional support on TB treatment outcomes, and to assess the role of diabetes on risk and severity of TB, and TB treatment outcomes. The study will be conducted in Mwanza Tanzania. All patients will initially be examined for HIV and diabetes. A total of 500 found pulmonary TB smear-positive (PTB+) and HIV positive (HIV+) will be randomised to a daily supplement of 1 versus 6 energy-protein bars throughout treatment, both with full multi-micronutrient (MN) content. A total of 1500 found pulmonary TB smear-negative (PTB-, irrespective of HIV status) and PTB+ and HIV negative (HIV-) will be randomised to 1 daily energy-protein bar containing either low or high MN content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New sputum smear positive or negative pulmonary TB patients
排除标准
- •pregnant, terminally ill, other serious diseases (except HIV and diabetes), non-residents
结局指标
主要结局
Weight gain
时间窗: 2 and 5 months
次要结局
- Grip strength(2 and 5 months)
- Arm muscle and arm fat areas(2 and 5 months)
- Physical activity(2 and 5 months)
- HIV load(2 months)
- CD4 count(2 and 5 months)
- Serum acute phase reactants(2 months)
- Mortality(12 month)
