Trial of Vitamin D in HIV Progression

Phase 3

Completed

• Conditions: HIV Infection
• Interventions: Dietary Supplement: Vitamin D3 (cholecalciferol); Other: Placebo

• Registration Number: NCT01798680
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Study Start: 2014-02
• Primary Completion: 2018-03
• Study Completion: 2019-03-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 (cholecalciferol)	Vitamin D3 (cholecalciferol)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
All-cause death	within 12 months after randomization
Pulmonary tuberculosis	within 12 months after randomization

Secondary Outcome Measures

Name	Time	Method
>10% weight loss	monthly from month 1 to month 12
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
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
Depression and anxiety scores	6 and 12 months after randomization
Alkaline phosphatase (ALP)	1, 6, and 12 months after randomization

Trial Locations

Locations (1)

Management and Development for Health (MDH); 🇹🇿 Dar es Salaam, Tanzania