Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health (ToV5)

April 22, 2020 updated by: Wafaie Fawzi
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania
        • Management and Development for Health (MDH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum
Experimental: Vitamin D3 (cholecalciferol)
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wafaie Fawzi

Collaborators

Management and Development for Health (MDH)

Investigators

  • Principal Investigator: Wafaie W Fawzi, MBBS, DrPH, Harvard School of Public Health (HSPH)
  • Principal Investigator: Christopher R Sudfeld, ScD, Harvard School of Public Health (HSPH)
  • Principal Investigator: Karim P Manji, MD, Management and Development for Health (MDH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2015

Primary Completion (Actual)

September 18, 2019

Study Completion (Actual)

September 18, 2019

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

November 29, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD083113 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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