Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Metabolic Clearance of D6-25(OH)D3
研究概览
简要总结
The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3 supplementation using a gold standard pharmacokinetic approach.
详细描述
We expect that this study will enhance interpretation of available diagnostic tests, inform the results of ongoing large clinical trials of vitamin D supplements, and help develop new strategies to target vitamin D to improve health.
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
- 否
入选标准
- •Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF (NCT03104855)
- •Age ≥ 18 years
- •Self-reported race Caucasian, African American, or African
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 (unless failed transplant now treated with hemodialysis)
- •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 < 10 g/dL
研究组 & 干预措施
Study Population
D6-25-hydroxyvitamin D3 with vitamin D3
干预措施: D6-25-hydroxyvitamin D3 (Drug)
结局指标
主要结局
Change in Metabolic Clearance of D6-25(OH)D3
时间窗: Baseline, 6 months
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. Change in clearance of D6-25(OH)D3 will be calculated as D6-25(OH)D3 clearance measured during CLEAR-PLUS minus D6-25(OH)D3 clearance previously measured during participation in the related study protocol (without vitamin D3 supplementation). Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration. The change listed is between two timepoints.
次要结局
- Change in AUC of D6-25(OH)D3(Baseline, 6 months)
- Change in Terminal Half-life of D6-25(OH)D3(Baseline, 6 months)
- Change in Volume of Distribution of D6-25(OH)D3(Baseline, 6 months)
研究者
Ian deBoer
Professor, Medicine/Nephrology
University of Washington