Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
研究概览
简要总结
The investigators are studying if taking simvastatin and vitamin D together will help prevent episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in certain foods like some types of fish, and in nutritional supplements. This study is 9 months long. Some people who participate will receive simvastatin and vitamin D, and some people will receive a placebo. A placebo is a "sugar pill" that looks like medication but does not have any active ingredients in it.
The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the number of migraines people who have episodic migraine get.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age 18 years or older
- •Have had migraines for at least 3 years
- •Have between 4 and 15 migraines a month
- •Able to speak and read the English language
排除标准
- •Women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months
- •Individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes
- •individuals at high risk for cardiovascular disease
研究组 & 干预措施
Simvastatin and vitamin D
Participants in this arm will receive simvastatin + vitamin D.
干预措施: Simvastatin (Drug)
Simvastatin and vitamin D
Participants in this arm will receive simvastatin + vitamin D.
干预措施: Vitamin D (Dietary Supplement)
Placebo "Sugar Pill"
Participants in this arm will take placebo pills, which look like the simvastatin and vitamin D. A placebo pill has no active medication in it, and is like taking a "sugar pill".
干预措施: Placebo (Other)
结局指标
主要结局
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
时间窗: Weeks 1 to 12
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
时间窗: Weeks 13 to 24
次要结局
未报告次要终点
研究者
Rami Burstein
Professor
Beth Israel Deaconess Medical Center