Statin/Vitamin D & Migraine Study
|ClinicalTrials.gov Identifier: NCT01225263|
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : January 26, 2016
Last Update Posted : January 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Simvastatin Dietary Supplement: Vitamin D Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Simvastatin and vitamin D
Participants in this arm will receive simvastatin + vitamin D.
simvastatin, 20 mg, twice daily for 6 months
Dietary Supplement: Vitamin D
Vitamin D3, 1000 IU, twice daily for 6 months
Placebo Comparator: 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".
Two placebo pills, taken twice daily for 6 months
- Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 [ Time Frame: Weeks 1 to 12 ]
- Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24 [ Time Frame: Weeks 13 to 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225263
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Catherine Buettner, MD, MPH||Beth Israel Deaconess Medical Center|
|Study Director:||Rami Burstein, PhD||Beth Israel Deaconess Medical Center|