A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory value
研究概览
简要总结
The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain or aches that may be caused by taking certain medications for treating high cholesterol.
详细描述
Participation in this study will consist of at least two study visits, expected to occur over a period of up to four weeks. Study-related medication will be provided at no cost to participants. Participants will receive either Vitamin D or placebo (sugar pill).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are between the ages of 18 and 88 years old
- •A muscle symptom defined as any of the following: Myalgia (muscle aches with normal CK); Myopathy (muscle aches with increased CK up to 5 times above the upper limit of normal); or Myopathy for the purpose of further evaluation (muscle aches with increased CK up to 5 times the upper limit of normal)
排除标准
- •Women who are pregnant, breastfeeding or planning to become pregnant
- •Morbidly obese with a BMI >40 kg/m2
- •Travel to southern states, areas near the Equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/UV rays exposure in the past 30 days or at any point during the trial
- •Currently (within the last 2 weeks) using any of the following supplements: Vitamin D-3 (Cholecalciferol) of more than 400 IU orally daily, which would not exclude typical multi-vitamin use; Vitamin D-2 (Ergocalciferol); Calcitriol; or Coenzyme Q10
- •Documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization
- •Renal dysfunction defined as glomerular filtration rate less than 60 mL/min.
- •Documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits
研究组 & 干预措施
Control
Subjects will take 3 capsules of placebo every day for 14 days
干预措施: Placebo (Other)
结局指标
主要结局
Brief Pain Inventory value
时间窗: 14 days
Decrease in the level of muscle pain, based on values of Brief Pain Inventory short forms completed at the initial clinic visit and approximately four weeks later at the final clinic visit
次要结局
未报告次要终点