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

NCT02305927 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2300

Last updated 2020-04-24

No results posted yet for this study

Summary

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).

Conditions

Interventions

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Management and Development for Health (MDH)

    collaborator UNKNOWN

  • Wafaie Fawzi

    lead OTHER

Principal Investigators

  • Wafaie W Fawzi, MBBS, DrPH · Harvard School of Public Health (HSPH)

  • Christopher R Sudfeld, ScD · Harvard School of Public Health (HSPH)

  • Karim P Manji, MD · Management and Development for Health (MDH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-15
Primary Completion
2019-09-18
Completion
2019-09-18

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305927 on ClinicalTrials.gov