Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 666
- 试验地点
- 5
- 主要终点
- Change in Serum 1,25(OH)2D Concentration
研究概览
简要总结
The goal of this clinical trial is to determine individual-level genetic and metabolic characteristics that modify the response to cholecalciferol treatment.
This study is double blind, parallel design, randomized clinical trial that will assess genetic and metabolic characteristics that modify the response to cholecalciferol treatment. . Eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000 international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total duration of 16-weeks. The planned sample size is 1,600. The primary aim of this study is to identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the biologic response to vitamin D3 treatment, assessed by changes in serum concentrations of parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •1,600 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) study who are returning for their scheduled 6th MESA study visit.
- •Participants will be recruited from four field centers: Wake Forest University, Winston-Salem, NC; Columbia University, New York, NY; Northwestern University, Evanston, IL; and Johns Hopkins University, Baltimore, MD.
排除标准
- •Current use of >1,000 international units (IU) of cholecalciferol daily
- •Current use of any activated vitamin D product (calcitriol, paricalcitol, hectorol)
- •Known history of allergy or adverse reaction to vitamin D treatment
- •Known clinical history of primary hyperparathyroidism
- •Known clinical history of kidney stones within the previous 5 years
- •Current participation in another interventional study
- •Inability to provide written informed consent
研究组 & 干预措施
Active Treatment
干预措施: Vitamin D3 (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum 1,25(OH)2D Concentration
时间窗: 16 weeks
Change in Serum PTH Concentration
时间窗: 16 weeks
次要结局
- Change in Systolic Blood Pressure(16 weeks)
- Change in Serum Calcium Concentrations(16 weeks)
- Change in Urine Calcium Excretion(16 weeks)
研究者
Ian deBoer
Associate Professor, Medicine/Nephrology
University of Washington