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Completed

NCT Number: NCT02305927

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

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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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Management and Development for Health (MDH)

Dar es Salaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D3 (cholecalciferol)

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

Other

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

Primary outcomes

  1. Proportion of participants experiencing maternal HIV progression

    Time frame: Second Trimester until 12 months post partum

  2. Proportion of small-for-gestational age infants

    Time frame: Birth

  3. Proportion of stunted infants (height-for-age z-score < -2)

    Time frame: 12 months postpartum (1 year of age)

Sponsors and collaborators

Lead sponsor

Wafaie Fawzi

Other

Collaborators

  • Management and Development for Health (MDH)

Registry information

Acronym: ToV5

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2014
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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