The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Endothelial Function
研究概览
简要总结
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).
详细描述
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy or Breast Feeding
- •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
研究组 & 干预措施
Placebo
Participants that have been randomized into this arm will receive placebo pills.
干预措施: Placebo (Other)
Vitamin D 4000 IU
Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Change in Endothelial Function
时间窗: Baseline and 12 weeks
Endothelial function measured by flow mediated brachial artery dilation
次要结局
- Change in Serum 25-hydroxyvitamin D Concentration in Both Groups(Baseline and 12 weeks)
研究者
Grace McComsey
Chief, Peds ID, Rheumatology and Global Health
University Hospitals Cleveland Medical Center