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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-15

Study Completion Date

2019-09-18

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3 (cholecalciferol)

Group Type EXPERIMENTAL

Vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum

Interventions

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Vitamin D3 (cholecalciferol)

Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum

Intervention Type OTHER

Eligibility Criteria

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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)