Vitamin D Replacement in Statin-Induced Myopathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- lack of need to stop statin medication due to myalgia
研究概览
简要总结
Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.
详细描述
Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.
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
- 是
入选标准
- •male and female adults
- •identified by their physician as having myalgia with their statin medication.
排除标准
- •Unexplained CK > 4X upper limit of normal, at study entry, or on a statin medication in the past.
- •Severe myositis
- •Consumption in excess of 14 alcoholic beverages per week
- •Situations which will cause difficulty in interpreting the vitamin D and / or PTH.
- •Present consumption of vitamin D supplements > 1000 iu daily
- •Renal impairment (Estimated creatinine clearance < 70 ± 14 mL/min/m2 in Males; and < 60 ± 10 mL/min/m2 in Females)
- •Chronic liver disease or impaired liver function
- •Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins
研究组 & 干预措施
Placebo
Subjects in this group will receive a placebo tablet (Lactose 100 mg) for the duration of the study
干预措施: Placebo (Drug)
Vitamin D
Subjects in this arm will receive a dose of 50,000 IU of vitamin D3, followed by weekly doses of 10,000 IU of vitamin D3
干预措施: Vitamin D (Cholecalciferol ) (Drug)
结局指标
主要结局
lack of need to stop statin medication due to myalgia
时间窗: 12 weeks
Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia
次要结局
- reduction of visual analog pain score(12 weeks)
研究者
Dr. Mark Sherman
Associate Professor (Clinical), Dept of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre