Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 25(OH)D
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.
详细描述
This is a randomized, single blind, controlled study. Subjects will be randomly assigned to receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2 group); or 3) capsules with cholecalciferol (the vitamin D3 group).
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis
排除标准
- •They will habitually consume less than 16 oz of milk per day and get less than 10 hours of sun exposure per week. We will exclude those with granulomatous conditions, cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids in any form or any investigational drugs within 4 weeks. We will exclude those with pregnancy or planned pregnancy, hypercalcemia (>10.4 mg/dl) previously recorded, chronic GI disease which would interfere with absorption, any allergy to vitamin D3, or chronic vitamin D intake >1,000 IU daily. Subjects will continue to take a calcitriol analogue and phosphorus binder as prescribed by their nephrologist. Calcitriol analogues are to be documented and remain constant throughout study.
研究组 & 干预措施
Placebo
a single oral dose of a placebo
干预措施: Placebo (Dietary Supplement)
Vitamin D3
A single oral dose of vitamin D3
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D2
a single oral dose of vitamin D2
干预措施: Vitamin D2 (Dietary Supplement)
结局指标
主要结局
25(OH)D
时间窗: 16 weeks
25(OH)D levels will be drawn at intervals over 16 weeks.
次要结局
未报告次要终点