Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Metabolic Clearance of D6-25(OH)D3
研究概览
简要总结
The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of this work is to provide the first comprehensive characterization of vitamin D metabolism in CF patients and promote novel hypotheses for subsequent studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Serum total 25(OH)D 10-50 ng/mL
- •Diagnosis of cystic fibrosis in accordance with CF Foundation Guidelines; OR, normal CONTROL
排除标准
- •Primary hyperparathyroidism
- •Gastric bypass
- •Tuberculosis or sarcoidosis
- •Current pregnancy
- •Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)
- •History of kidney transplantation or end stage renal disease treated with dialysis
- •Use of vitamin D3 or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed)
- •Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)
- •Serum calcium > 10.1 mg/dL
- •Hemoglobin < 9 g/dL
研究组 & 干预措施
Single pharmacokinetics arm
干预措施: d6-25-hydroxyvitamin D3 (Drug)
结局指标
主要结局
Metabolic Clearance of D6-25(OH)D3
时间窗: 8 weeks
Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method.
次要结局
- AUC of D6-25(OH)D3(8 weeks)
- Terminal Half-life of D6-25(OH)D3(8 weeks)
- Volume of Distribution of D6-25(OH)D3(8 weeks)
研究者
Ian deBoer
Associate Professor, Medicine/Nephrology
University of Washington