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临床试验/NCT00057434
NCT00057434已完成3 期

Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS

National Institute of Allergy and Infectious Diseases (NIAID)1 个研究点 分布在 1 个国家目标入组 1,140 人开始时间: 1998年9月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,140
试验地点
1
主要终点
Mortality

研究概览

简要总结

The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.

详细描述

By the year 2000, 13.8 % of individuals with HIV will be co-infected with tuberculosis (TB). Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple, inexpensive intervention is available. Prior to the discovery of antibiotic treatment, cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB. Vitamin A is essential for normal immune function, and Vitamin A supplementation is used in many countries to reduce mortality in children. Vitamin A deficiency in HIV infected people has been associated with increased mortality in the United States, Haiti, Malawi, and Uganda. This study will determine whether daily Vitamin A supplementation, given concurrently with TB chemotherapy, will reduce mortality in adults with HIV and TB.

All study participants will receive standard TB chemotherapy (isoniazid, rifampicin, streptomycin, pyrazinamide) for the first 2 months, followed by isoniazid and ethambutol for the following 6 months. Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo. Participants will be followed for 24 months after study enrollment.

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
Double

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sputum-confirmed pulmonary tuberculosis
  • Resident of Zomba or Blantyre Districts, Malawi
  • Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme

排除标准

  • Prior treatment for tuberculosis

结局指标

主要结局

Mortality

次要结局

  • Morbidity

研究者

研究点 (1)

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