Vitamin D Supplementation and HIV-related Complications in Children and Young Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Changes in Serum 25(OH)D3 Levels
研究概览
简要总结
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
详细描述
The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 8-25
- •Documented HIV-1 infection
- •On stable antiretroviral therapy for > 3 months
- •Cumulative antiretroviral therapy of at least 6 months
- •25(OH)D level < 30 ng/ml at screening
排除标准
- •> 400 IU daily regular vitamin D intake
- •Parathyroid/calcium disorders
- •Active malignancy
- •Pregnancy/intent to become pregnant/breastfeeding
- •Chronic infectious/inflammatory conditions
- •Creatinine clearance < 50 ml/min
- •Hemoglobin < 9.0 g/dL
- •Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal
- •Diabetes requiring hypoglycemic agents
- •Known coronary artery disease
- •Inability to swallow pills
研究组 & 干预措施
HIV + Young Adults
All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
干预措施: Vitamin D control dose (Drug)
HIV + Young Adults
All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
干预措施: Vitamin D supplementation- (Drug)
HIV - Controls
HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
干预措施: Vitamin D control dose (Drug)
HIV - Controls
HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
干预措施: Vitamin D supplementation- (Drug)
结局指标
主要结局
Changes in Serum 25(OH)D3 Levels
时间窗: 6 months
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )
次要结局
- Changes in Vitamin D Binding Protein (VDBP)(6 months)
研究者
Grace McComsey
Professor of Pediatrics and Medicine, Chief Pediatric Infectious Diseases, Rheumatology and Global Health
University Hospitals Cleveland Medical Center