Statin/Vitamin D & Migraine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225263
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : January 26, 2016
Last Update Posted : January 26, 2016
Information provided by (Responsible Party):
Rami Burstein, Beth Israel Deaconess Medical Center

September 30, 2010
October 20, 2010
December 17, 2015
January 26, 2016
January 26, 2016
September 2010
January 2015   (Final data collection date for primary outcome measure)
  • 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 ]
Migraine frequency [ Time Frame: Month 9 ]
Frequency of migraine attacks
Complete list of historical versions of study NCT01225263 on Archive Site
Not Provided
Duration of Migraine [ Time Frame: Month 9 ]
Duration of each migraine attack
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Statin/Vitamin D & Migraine Study
Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine

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.

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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Drug: Simvastatin
    simvastatin, 20 mg, twice daily for 6 months
  • Dietary Supplement: Vitamin D
    Vitamin D3, 1000 IU, twice daily for 6 months
  • Other: Placebo
    Two placebo pills, taken twice daily for 6 months
  • Experimental: Simvastatin and vitamin D
    Participants in this arm will receive simvastatin + vitamin D.
    • Drug: Simvastatin
    • Dietary Supplement: Vitamin D
  • 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".
    Intervention: Other: Placebo
Buettner C, Nir RR, Bertisch SM, Bernstein C, Schain A, Mittleman MA, Burstein R. Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial. Ann Neurol. 2015 Dec;78(6):970-81. doi: 10.1002/ana.24534. Epub 2015 Nov 13.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Rami Burstein, Beth Israel Deaconess Medical Center
Rami Burstein
Not Provided
Principal Investigator: Catherine Buettner, MD, MPH Beth Israel Deaconess Medical Center
Study Director: Rami Burstein, PhD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP