Trial of Vitamin D in HIV Progression (TOV4)
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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 anti-retroviral 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 |
- 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 ]
- 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: | September 2013 |
| 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 |
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| Contact: Wafaie W Fawzi, MBBS, DrPH | 617-432-5299 | mina@hsph.harvard.edu |
| Tanzania | |
| Management and Development for Health (MDH) | Not yet recruiting |
| Dar es Salaam, Tanzania | |
| Contact: Ferdinand M Mugusi, MD fmugusi@muhas.ac.tz | |
| 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 22, 2013 |
| 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 May 23, 2013