Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in pain score
研究概览
简要总结
This proposal will explore muscle function (strength and endurance) in men and women suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle symptoms will be explored. Also, the investigators will assess the potential usefulness of vitamin D supplementation in a randomized control trial.
详细描述
Statins are a class of drugs that are widely prescribed to lower blood cholesterol levels. Although they have few side effects, many patients report muscle pain, cramps, and weakness when using these drugs. We know very little on the real impact of these muscle symptoms on patient quality of life, especially in relation to muscle strength and endurance.
Patients under statin therapy will stop medication for 2 months. Results from blood sample, muscle function and muscle biopsy (in some participants) will be compared with baseline. Participants will then take vitamin D supplementation or placebo for one month. Thereafter, statin will be reintroduced for two months while continuing vitamin D or placebo supplementation. At the end of that time, measures from blood sample, muscle function and muscle biopsy will be compared with other visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •statin therapy
- •healthy and sedentary or moderately physical active
排除标准
- •Current treatment with other lipid-lowering drugs
- •Natural medicine affecting lipid metabolism
- •CK levels above the normal range
- •Clinical vitamin D deficiency
- •Impaired liver or kidney function
- •Untreated hypo- or hyperthyroidism
- •Treatment with other medications known to increase risk of myopathy
- •Existing infection requiring antibiotic therapy
- •Consumption of greater than 60 ml of grapefruit juice per day
- •Inherited muscle disorders or myopathy
- •Polymyositis or inflammatory myopathy
- •Use of corticosteroids
- •Comorbidities resulting in muscle or bone pain
- •History of elevated CK
- •Unexplained cramps
- •Known sickle cell trait
- •Cancer within the 5 years prior to study entry
- •Stroke, coronary artery or peripheral vascular disease
- •Physical disability or previous injury interfering with exercise testing
- •Pregnant or breastfeeding
- •Depression (in last 3 years) or treatment with antidepressants
- •Use of anti-psychotic drugs
- •Alcohol abuse
研究组 & 干预措施
Vitamin D
干预措施: Vitamin D (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in pain score
时间窗: Change from baseline at 2 months
Change in muscle function testing
时间窗: Change from baseline at 2 months
Strenght and endurance evaluation
次要结局
- Change in muscle histology(Change from baseline at 5 months)
- Change in pain score(Change from baseline at 5 months)
- Change in muscle function testing(Change from baseline at 5 months)