Vitamin D, Immune Activation, and Metabolic Abnormalities in HIV-Infected Patients on Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.
研究概览
简要总结
This is a research study to look at vitamin D deficiency (low levels) in men and women with HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If your levels are low, and you choose to start using vitamin D supplements, the investigators would like to take some blood before and after you start using vitamin D to see how this affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study. If you and your physician decide that you should continue taking vitamin D supplements after that time, you will be responsible for purchasing your own vitamin D supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive men and women age 18 and older.
- •HIV-1 RNA documented to be < 200 copies/mL on their current ART regimen, with supporting viral load documentation in the 24 weeks prior to study entry.
- •Subjects must receive primary HIV care at the UCLA CARE center.
- •Subjects must be undergoing screening for vitamin D deficiency by their primary care provider at the time of study entry, or have undergone vitamin D screening in the 90 days prior to consent without yet initiating vitamin D supplementation (for insufficient subjects).
- •Ability and willingness of subject to provide informed consent
排除标准
- •Use of vitamin D supplementation (not including 400 IU daily, the amount in a standard multivitamin) at the time of screening.
- •HIV-infected subjects not on ART.
- •HIV-infected subjects not suppressed on their current ART regimen (HIV-1 RNA > 200 copies/mL in the 6 months prior to screening).
研究组 & 干预措施
Vitamin D Insufficient
HIV-infected men and women with HIV-1 viral load <200 copies /mL on stable ART and 25(OH)D level <30ng/mL receive 50,000 IU twice weekly for 5 weeks followed by 2000 IU daily to complete 12 weeks.
干预措施: Vitamin D (Dietary Supplement)
Vitamin D Sufficient
HIV-infected men and women with HIV-1 viral load <200 copies/mL on stable ART and 25(OH)D level ≥30ng/mL receive no intervention.
结局指标
主要结局
Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.
时间窗: 12 weeks
Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.
次要结局
未报告次要终点
研究者
Jordan E. Lake M.D.
M.D.
University of California, Los Angeles