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Trial of Vitamin D in HIV Progression

NCT01798680 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2019-08-09

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of vitamin D3 (cholecalciferol) supplementation on HIV progression and incidence of pulmonary tuberculosis among HIV-positive Tanzanian adult men and women initiating highly active antiretroviral therapy (HAART).

Conditions

  • HIV Infection

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol)

Supplements containing 50,000 IU of vitamin D3 (cholecalciferol) taken orally once per week for 4 weeks (weeks 0, 1, 2, 3) followed by 2,000 IU of vitamin D3 (cholecalciferol) supplements taken orally once per day starting at 4 weeks until study discharge at 12 months

OTHER

Placebo

Placebo pills taken once weekly for 4 weeks (weeks 0, 1, 2, 3) followed by placebo pills taken orally once per day starting at 4 weeks until study discharge at 12 months

Sponsors & Collaborators

  • Management and Development for Health (MDH)

    collaborator UNKNOWN

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

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

  • Ferdinand M Mugusi, MD · Management and Development for Health (MDH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-03-31
Completion
2019-03-31

Countries

  • Tanzania

Study Locations

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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 NCT01798680 on ClinicalTrials.gov