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
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-
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Dar es Salaam, Tanzania
- Management and Development for Health (MDH)
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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
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Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum
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Experimental: Vitamin D3 (cholecalciferol)
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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
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Second Trimester until 12 months post partum
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|
Proportion of small-for-gestational age infants
Time Frame: Birth
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Birth
|
|
Proportion of stunted infants (height-for-age z-score < -2)
Time Frame: 12 months postpartum (1 year of age)
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12 months postpartum (1 year of age)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Sudfeld CR, Manji KP, Duggan CP, Aboud S, Muhihi A, Sando DM, Al-Beity FMA, Wang M, Fawzi WW. Effect of maternal vitamin D3 supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial. Trials. 2017 Sep 4;18(1):411. doi: 10.1186/s13063-017-2157-3.
- Sudfeld CR, Manji KP, Muhihi A, Duggan CP, Aboud S, Alwy Al-Beity FM, Wang M, Zhang N, Ulenga N, Fawzi WW. Vitamin D3 supplementation during pregnancy and lactation for women living with HIV in Tanzania: A randomized controlled trial. PLoS Med. 2022 Apr 15;19(4):e1003973. doi: 10.1371/journal.pmed.1003973. eCollection 2022 Apr.
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.