Status:
COMPLETED
Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
Lead Sponsor:
Wafaie Fawzi
Collaborating Sponsors:
Management and Development for Health (MDH)
Conditions:
HIV
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- Enrolled in any other clinical trial
Key Trial Info
Start Date :
June 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
2300 Patients enrolled
Trial Details
Trial ID
NCT02305927
Start Date
June 15 2015
End Date
September 18 2019
Last Update
April 24 2020
Active Locations (1)
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1
Management and Development for Health (MDH)
Dar es Salaam, Tanzania