Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Wafaie Fawzi
- Enrollment
- 2300
- Locations
- 1
- Primary Endpoint
- Proportion of stunted infants (height-for-age z-score < -2)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Wafaie Fawzi
Professor of Nutrition, Epidemiology, and Global Health
Harvard School of Public Health (HSPH)
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •Enrolled in any other clinical trial
Outcomes
Primary Outcomes
Proportion of stunted infants (height-for-age z-score < -2)
Time Frame: 12 months postpartum (1 year of age)
Proportion of participants experiencing maternal HIV progression
Time Frame: Second Trimester until 12 months post partum
Proportion of small-for-gestational age infants
Time Frame: Birth