hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- hCAP18 levels
研究概览
简要总结
The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)
排除标准
- •6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis
- •use of active vitamin D analog within 30 days
- •functioning renal transplant
- •Symptoms of active infection
- •Granulomatous disorders
研究组 & 干预措施
ergocalciferol
Ergocalciferol intervention arm
干预措施: Ergocalciferol (Drug)
calcitriol
calcitriol intervention arm
干预措施: Calcitriol (Drug)
结局指标
主要结局
hCAP18 levels
时间窗: 2 weeks
次要结局
- 25-hydroxyvitamin D(2 weeks)
- Parathyroid hormone(2 weeks)
- calcium(2 weeks)
- T-cell subsets(2 weeks)
- phosphorus(2 weeks)
- 1,25-dihydroxyvitamin D(2 weeks)
研究者
Ishir Bhan, MD, MPH
Assistant in Medicine
Massachusetts General Hospital