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

Study Overview
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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).

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.

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

Conditions
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HIV

Intervention / Treatment
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* Dietary Supplement: Vitamin D3 (cholecalciferol)
* Other: Placebo


Participation Criteria
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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) Exclusion Criteria: Enrolled in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 (cholecalciferol)<br> | Dietary Supplement: Vitamin D3 (cholecalciferol)<br>* Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Pregnant women