Trial of Vitamins in HIV Progression and Transmission
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,085
- 试验地点
- 1
- 主要终点
- To examine the effect of multivitamin and/or Vitamin A supplements on the risk of perinatal transmission of HIV and rate of HIV disease progression
研究概览
简要总结
This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.
详细描述
In this study, we sought to examine whether the administration of multivitamins excluding vitamin A, multivitamins including vitamin A, or vitamin A alone would reduce the risk of perinatal transmission of HIV and slow the rate of disease progression in a group of pregnant HIV infected women. We also examined the efficacy of the supplements on pregnancy outcomes, and risks of maternal and child morbidity and wasting.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation:
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Other)
Multivitamins
Vitamins B, C, and E
干预措施: Multivitamins (Dietary Supplement)
Vitamin A + Multivitamins
Vitamin A + Beta Carotene, Vitamins B, C, and E
干预措施: Vitamin A + Beta Carotene (Dietary Supplement)
Vitamin A + Multivitamins
Vitamin A + Beta Carotene, Vitamins B, C, and E
干预措施: Multivitamins (Dietary Supplement)
Vitamin A
Vitamin A + Beta Carotene
干预措施: Vitamin A + Beta Carotene (Dietary Supplement)
结局指标
主要结局
To examine the effect of multivitamin and/or Vitamin A supplements on the risk of perinatal transmission of HIV and rate of HIV disease progression
时间窗: until the end of follow-up in August, 2003
次要结局
- To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality(until the end of follow-up in August 2003)