Vitamin D Replacement: The Effect on Statin-Related Myalgias
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy
研究概览
简要总结
The purpose of this project is to determine if Vitamin D supplementation [10,000 international units of cholecalciferol (vitamin D3) by mouth weekly] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days)
- •Patients aged 19-89 years old
- •Men and women (not of childbearing potential)
- •Patients receiving statins with concomitant ezetimibe
排除标准
- •history of alcoholism or malnutrition
- •receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels
研究组 & 干预措施
Vitamin D
Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
干预措施: cholecalciferol/placebo (Drug)
Placebo
Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
干预措施: cholecalciferol/placebo (Drug)
结局指标
主要结局
Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy
时间窗: 6 months
次要结局
未报告次要终点