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临床试验/NCT00311298
NCT00311298已完成3 期

The Role of Nutritional Support and Diabetes During Treatment of Pulmonary TB: Two Randomized Nutritional Supplementation Trials in Tanzania

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2006年4月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (1)

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