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Trial of Vitamin D in HIV Progression (TOV4)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01798680
First Posted: February 26, 2013
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Management and Development for Health (MDH)
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
February 21, 2013
February 26, 2013
March 15, 2017
February 2014
March 2018   (Final data collection date for primary outcome measure)
  • All-cause death [ Time Frame: within 12 months after randomization ]
  • Pulmonary tuberculosis [ Time Frame: within 12 months after randomization ]
Same as current
Complete list of historical versions of study NCT01798680 on ClinicalTrials.gov Archive Site
  • CD4+ T-cell count [ Time Frame: 6 and 12 months after randomization ]
  • Physician diagnosis of comorbidities [ Time Frame: within 12 months after randomization ]
  • Parathyroid hormone (PTH) [ Time Frame: 1, 6, and 12 months after randomization ]
  • Alkaline phosphatase (ALP) [ Time Frame: 1, 6, and 12 months after randomization ]
  • >10% weight loss [ Time Frame: monthly from month 1 to month 12 ]
  • Wasting (BMI <18.5 kg/m2) [ Time Frame: monthly from month 1 to month 12 ]
  • Hypercalcemia [ Time Frame: 1, 6, and 12 months after randomization ]
  • Physical activity [ Time Frame: 6 and 12 months after randomization ]
  • Immunologic biomarker levels (IL-2, IL-12, IFN-γ, and cathelicidin) [ Time Frame: 1, 6, and 12 months after randomization ]
  • Depression and anxiety scores [ Time Frame: 6 and 12 months after randomization ]
  • CD4+ T-cell count [ Time Frame: 4, 8, and 12 months after randomization ]
  • Physician diagnosis of comorbidities [ Time Frame: within 12 months after randomization ]
  • Parathyroid hormone (PTH) [ Time Frame: 4, 8, and 12 months after randomization ]
  • Alkaline phosphatase (ALP) [ Time Frame: 4, 8, and 12 months after randomization ]
  • Weight [ Time Frame: monthly from month 1 to month 12 ]
  • Hypercalcemia [ Time Frame: 1, 6, and 12 months after randomization ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4000
March 2018
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
 
NCT01798680
R01DK098075( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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
March 2017

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