Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health

Phase 3

Completed

• Conditions: HIV
• Interventions: Other: Placebo; Dietary Supplement: Vitamin D3 (cholecalciferol)

• Registration Number: NCT02305927
• Lead Sponsor: Wafaie Fawzi

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.

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-11-29
• Study First Posted: 2014-12-03
• Study Start: 2015-06-15
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vitamin D3 (cholecalciferol)	Vitamin D3 (cholecalciferol)	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants experiencing maternal HIV progression	Second Trimester until 12 months post partum
Proportion of small-for-gestational age infants	Birth
Proportion of stunted infants (height-for-age z-score < -2)	12 months postpartum (1 year of age)

Trial Locations

Locations (1)

Management and Development for Health (MDH); 🇹🇿 Dar es Salaam, Tanzania