Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
Phase 2
Completed
- Conditions
- Human Immunodeficiency Virus (HIV)HIV InfectionsVitamin D Deficiency
- Interventions
- Other: Placebo
- Registration Number
- NCT01093417
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- Brief Summary
The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).
- Detailed Description
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- HIV infected
- HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior
- 25-hydroxyvitamin D level <20
- On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry
Exclusion Criteria
- Pregnancy or Breast Feeding
- Diabetes
- Creatinine Clearance <50
- Any active infectious or inflammatory condition
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months prior to study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants that have been randomized into this arm will receive placebo pills. Vitamin D 4000 IU Vitamin D Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.
- Primary Outcome Measures
Name Time Method Change in Endothelial Function Baseline and 12 weeks Endothelial function measured by flow mediated brachial artery dilation
- Secondary Outcome Measures
Name Time Method Change in Serum 25-hydroxyvitamin D Concentration in Both Groups Baseline and 12 weeks
Trial Locations
- Locations (1)
University Hospitals of Cleveland Case Medical Center
🇺🇸Cleveland, Ohio, United States