Trial of Vitamin D in HIV Progression (TOV4)

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: HIV Infection

Treatments: Other: Placebo; Dietary Supplement: Vitamin D3 (cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT01798680

R01DK098075

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

4,000 participants in 2 patient groups, including a placebo group

Vitamin D3 (cholecalciferol)

Experimental group

Treatment:

Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo

Placebo Comparator group

Treatment:

Other: Placebo