Statin/Vitamin D & Migraine Study
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|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|
|Primary Completion Date :||January 2015|
|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 monthsDietary 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|