This trial is active, not recruiting.

Condition migraine
Treatments simvastatin, vitamin d, placebo
Phase phase 2
Sponsor Rami Burstein
Start date September 2010
End date December 2015
Trial size 80 participants
Trial identifier NCT01225263, 2010P000118


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Participants in this arm will receive simvastatin + vitamin D.
simvastatin, 20 mg, twice daily for 6 months
vitamin d
Vitamin D3, 1000 IU, twice daily for 6 months
(Placebo Comparator)
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

Primary Outcomes

Migraine frequency
time frame: Month 9

Secondary Outcomes

Duration of Migraine
time frame: Month 9

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine
Principal investigator Catherine Buettner, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.