Trial of Vitamins Among Children of HIV-infected Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,387
- 试验地点
- 1
- 主要终点
- All-cause mortality and diarrheal morbidity
研究概览
简要总结
The purpose of this study is to examine the effects of multivitamin (B, C, E) supplementation on reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.
详细描述
An increasing body of evidence supports the efficacy of single and, more recently, multiple micronutrient supplementation in reducing morbidity and mortality in susceptible populations. For example, we recently completed a multiple micronutrient supplementation trial in HIV-positive Tanzanian women that showed a significant reduction in pre-term birth, fetal loss, and low birthweight. In children, we and others have also demonstrated the beneficial effects of vitamin A supplementation in reducing diarrheal disease and mortality. Our next priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible children. Children born to HIV-infected women are at risk of multiple micronutrient deficiencies due to poor dietary intake, malabsorption, and increased metabolic needs. In addition, these children, if HIV-infected themselves, are at significantly higher risk of death due to infectious illnesses compared to their non-infected peers. In this study, we propose to study the efficacy of micronutrient supplementation in reducing the risk of morbidity and mortality outcomes among children born to HIV positive mothers, compared to placebo supplementation.
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
- 6 Weeks 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Singleton, live born infants born to HIV-infected women
排除标准
- •Infants with multiple congenital abnormalities
研究组 & 干预措施
Multivitamins
Vitamin E, Vitamin C, and Vitamin B complex
干预措施: Multivitamins - vitamins B complex, C and E (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause mortality and diarrheal morbidity
时间窗: age 6 weeks to age 24 months
次要结局
- Child growth faltering, lower respiratory infections, HIV breastfeeding transmission, and maternal HIV disease progression in relation to breastfeeding(age 6 weeks to 24 months post partum)
