Trial record 18 of 44 for:    " January 23, 2013":" February 22, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Harvard School of Public Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4000
Study Start Date: February 2014
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798680

Contacts
Contact: Wafaie W Fawzi, MBBS, DrPH 617-432-5299 mina@hsph.harvard.edu

Locations
Tanzania
Management and Development for Health (MDH) Recruiting
Dar es Salaam, Tanzania
Contact: Ferdinand M Mugusi, MD       fmugusi@muhas.ac.tz   
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

No publications provided

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
Study First Received: February 21, 2013
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board
Tanzania: Food & Drug Administration
Tanzania: National Institute for Medical Research

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

ClinicalTrials.gov processed this record on July 31, 2014