Trial of Vitamin D in HIV Progression

HIV Infection Clinical Trial

— TOV4  

Official title:

Trial of Vitamin D in HIV Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798680
• Other study ID #: R01DK098075
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2019
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: March 31, 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Tanzania	Management and Development for Health (MDH)	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Management and Development for Health (MDH)

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

Sudfeld CR, Mugusi F, Aboud S, Nagu TJ, Wang M, Fawzi WW. Efficacy of vitamin D(3) supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial. Trials. 2017 Feb 10;18(1):66. doi: 10.1186/s13063-017-1819-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death		within 12 months after randomization
Primary	Pulmonary tuberculosis		within 12 months after randomization
Secondary	CD4+ T-cell count		6 and 12 months after randomization
Secondary	Physician diagnosis of comorbidities		within 12 months after randomization
Secondary	Parathyroid hormone (PTH)		1, 6, and 12 months after randomization
Secondary	Alkaline phosphatase (ALP)		1, 6, and 12 months after randomization
Secondary	>10% weight loss		monthly from month 1 to month 12
Secondary	Wasting (BMI <18.5 kg/m2)		monthly from month 1 to month 12
Secondary	Hypercalcemia		1, 6, and 12 months after randomization
Secondary	Physical activity		6 and 12 months after randomization
Secondary	Immunologic biomarker levels (IL-2, IL-12, IFN-?, and cathelicidin)		1, 6, and 12 months after randomization
Secondary	Depression and anxiety scores		6 and 12 months after randomization