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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
  Purpose
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).

Condition Intervention Phase
HIV Infection Dietary Supplement: Vitamin D3 (cholecalciferol) Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Vitamin D in HIV Progression

Resource links provided by NLM:


Further study details as provided by Wafaie Fawzi, Harvard School of Public Health:

Primary Outcome Measures:
  • All-cause death [ Time Frame: within 12 months after randomization ]
  • Pulmonary tuberculosis [ Time Frame: within 12 months after randomization ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4000
Actual Study Start Date: February 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3 (cholecalciferol) 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
Placebo Comparator: Placebo 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798680


Locations
Tanzania
Management and Development for Health (MDH)
Dar es Salaam, Tanzania
Sponsors and Collaborators
Harvard School of Public Health
Management and Development for Health (MDH)
Investigators
Principal Investigator: Wafaie W Fawzi, MBBS, DrPH Harvard School of Public Health
Principal Investigator: Ferdinand M Mugusi, MD Management and Development for Health (MDH)
  More Information

Publications:
Responsible Party: Wafaie Fawzi, Professor of Nutrition, Epidemiology, and Global Health, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01798680     History of Changes
Other Study ID Numbers: R01DK098075 ( U.S. NIH Grant/Contract )
First Submitted: February 21, 2013
First Posted: February 26, 2013
Last Update Posted: March 15, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents