Vitamin D Supplementation and CD4 Count in HIV-Infected Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in CD4 percent associated with vitamin D supplementation in HIV-infected children
研究概览
简要总结
To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care
详细描述
The objective of this study is to determine the impact of vitamin D on immunological status in HIV-infected children as measured by CD4 count (CD4 percent). We will determine if vitamin D supplementation leads to a measurable change in CD4 count (CD4 percent) in HIV-infected children in the context of routine clinical care.
Specific study questions are:
- Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in HIV-infected children?
- Do the serum levels of the active form of vitamin D [1, 25(OH)2D and 25(OH)D] correlate with CD4 percent (CD4 count) in HIV-infected children?
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected children as defined by ≥ 2 positive HIV DNA PCRs and/or HIV cultures of blood for children less than 18 months of age, or by positive screening and confirmatory serologic testing in those older than 18 months of age
- •Stable HIV disease, defined by the absence of change in HIV clinical or immunologic category during the preceding 6 month period, prior to commencing the study
- •Age 3 years through 18 years
- •Voluntary informed consent
排除标准
- •Any antiretroviral medication change in the 6 months prior to the study, or any anticipated antiretroviral medication change during the duration of the study
- •Active participation in another treatment trial
- •Serum calcium < 2mmol/L at baseline
研究组 & 干预措施
1
干预措施: No supplementation (Drug)
2
干预措施: Vitamin D (Dietary Supplement)
3
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Change in CD4 percent associated with vitamin D supplementation in HIV-infected children
时间窗: 6 months
次要结局
- Change in absolute CD4 count with vitamin D supplementation(6 months)
- Change in HIV viral load with vitamin D supplementation(6 months)
- Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent(6 months)
- Other measures of vitamin D metabolism including serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (PTH), and urinary calcium/creatinine ratio(0, 3 and 6 months)
研究者
Ari Bitnun
Staff Physician
The Hospital for Sick Children