Trial of Vitamin D in HIV Progression
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HIV Infection
- Sponsor
- Harvard School of Public Health (HSPH)
- Enrollment
- 4000
- Locations
- 1
- Primary Endpoint
- All-cause death
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
Detailed Description
HIV-infected adults initiating antiretroviral therapy in resource-limited settings experience high mortality, pulmonary tuberculosis, and other comorbidity rates during the first year of HIV treatment. Observational studies have shown low vitamin D is a risk factor for HIV progression and incidence of pulmonary tuberculosis among adults initiating HAART; however, whether this relationship is causal and if vitamin D supplementation starting at HAART initiation can improve health outcomes has not been determined. This study is a randomized, double-blind, placebo-controlled trial conducted to examine the effect of vitamin D3 supplementation on morality and pulmonary tuberculosis for adults initiating HAART. Participants are HIV-positive Tanzanian men and women aged 18 years and older, who are initiating HAART at the time of randomization whose baseline 25-hydroxyvitamin D (25(OH)D) concentration is \<30ng/mL. Eligible individuals are randomized to receive a) a vitamin D3 regimen consisting 50,000 IU of vitamin D3 taken orally once per week for 4 weeks (weeks 0, 1, 2, 3) followed by 2,000 IU of vitamin D3 supplements taken orally once per day starting at 4 weeks until study discharge at 12 months or b) placebo pills taken once weekly for 4 weeks (weeks 0, 1, 2, 3) followed by placebo pills taken daily starting at 4 weeks until study discharge. Participants will be followed for 12 months after ART initiation.
Investigators
Wafaie Fawzi
Professor of Nutrition, Epidemiology, and Global Health
Harvard School of Public Health (HSPH)
Eligibility Criteria
Inclusion Criteria
- •HIV-positive
- •Men or Women
- •18 Years of Age or older
- •Initiating HAART at time of randomization
- •25(OH)D concentration \<30 ng/mL at HAART initiation
Exclusion Criteria
- •Pregnant Women
- •Enrolled in another micronutrient trial
Outcomes
Primary Outcomes
All-cause death
Time Frame: within 12 months after randomization
Pulmonary tuberculosis
Time Frame: within 12 months after randomization
Secondary Outcomes
- >10% weight loss(monthly from month 1 to month 12)
- Physician diagnosis of comorbidities(within 12 months after randomization)
- Wasting (BMI <18.5 kg/m2)(monthly from month 1 to month 12)
- Hypercalcemia(1, 6, and 12 months after randomization)
- Alkaline phosphatase (ALP)(1, 6, and 12 months after randomization)
- Physical activity(6 and 12 months after randomization)
- Immunologic biomarker levels (IL-2, IL-12, IFN-γ, and cathelicidin)(1, 6, and 12 months after randomization)
- Parathyroid hormone (PTH)(1, 6, and 12 months after randomization)
- CD4+ T-cell count(6 and 12 months after randomization)
- Depression and anxiety scores(6 and 12 months after randomization)