Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Proportion of stunted infants (height-for-age z-score < -2)
研究概览
简要总结
The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol) supplementation on maternal HIV progression, small-for-gestational age infants, and infant stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving highly active antiretroviral therapy (HAART).
详细描述
The study is a randomized, double-blind, placebo-controlled trial of maternal vitamin D3 (cholecalciferol) supplementation starting in the second trimester (12-27 weeks gestation) and continuing until 12 months postpartum among HIV-infected Tanzanian pregnant women who are receiving HAART. Eligible individuals are randomized to receive a) a vitamin D3 regimen consisting 3,000 IU of vitamin D3 taken orally once daily starting in the second trimester and continuing until 12 months postpartum or b) a placebo regimen taken orally once daily starting in the second trimester and continuing until 12 months postpartum. Mothers will be followed at study visits during pregnancy and mother/infant pairs will attend study visits from birth until trial discharge at 12 months postpartum.
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
- •Women aged ≥18 years old
- •HIV-positive
- •Receiving HAART
- •Pregnant and of 12-27 weeks gestation (Second Trimester)
- •Calcium levels in the normal physiologic range (≤2.6 mmol/L)
排除标准
- •Enrolled in any other clinical trial
结局指标
主要结局
Proportion of stunted infants (height-for-age z-score < -2)
时间窗: 12 months postpartum (1 year of age)
Proportion of participants experiencing maternal HIV progression
时间窗: Second Trimester until 12 months post partum
Proportion of small-for-gestational age infants
时间窗: Birth
次要结局
未报告次要终点
研究者
Wafaie Fawzi
Professor of Nutrition, Epidemiology, and Global Health
Harvard School of Public Health (HSPH)