Trial of Vitamin D in HIV Progression (TOV4)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Harvard School of Public Health
Sponsor:
Collaborator:
Management and Development for Health (MDH)
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01798680
First received: February 21, 2013
Last updated: February 27, 2014
Last verified: February 2014

February 21, 2013
February 27, 2014
February 2014
March 2018   (final data collection date for primary outcome measure)
  • All-cause death [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: No ]
  • Pulmonary tuberculosis [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01798680 on ClinicalTrials.gov Archive Site
  • CD4+ T-cell count [ Time Frame: 4, 8, and 12 months after randomization ] [ Designated as safety issue: No ]
  • Physician diagnosis of comorbidities [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: No ]
  • Parathyroid hormone (PTH) [ Time Frame: 4, 8, and 12 months after randomization ] [ Designated as safety issue: No ]
  • Alkaline phosphatase (ALP) [ Time Frame: 4, 8, and 12 months after randomization ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: monthly from month 1 to month 12 ] [ Designated as safety issue: No ]
  • Hypercalcemia [ Time Frame: 1, 6, and 12 months after randomization ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trial of Vitamin D in HIV Progression
Trial of Vitamin D in HIV Progression

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infection
  • 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
  • Experimental: Vitamin D3 (cholecalciferol)
    Intervention: Dietary Supplement: Vitamin D3 (cholecalciferol)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
Not Provided
March 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Wafaie W Fawzi, MBBS, DrPH 617-432-5299 mina@hsph.harvard.edu
Tanzania
 
NCT01798680
R01DK098075
Yes
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
Management and Development for Health (MDH)
Principal Investigator: Wafaie W Fawzi, MBBS, DrPH Harvard School of Public Health
Principal Investigator: Ferdinand M Mugusi, MD Management and Development for Health (MDH)
Harvard School of Public Health
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP