Statin/Vitamin D & Migraine Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rami Burstein, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01225263
First received: September 30, 2010
Last updated: March 26, 2013
Last verified: March 2013

September 30, 2010
March 26, 2013
September 2010
May 2013   (final data collection date for primary outcome measure)
Migraine frequency [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
Frequency of migraine attacks
Same as current
Complete list of historical versions of study NCT01225263 on ClinicalTrials.gov Archive Site
Duration of Migraine [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
Duration of each migraine attack
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Migraine
  • 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.
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
August 2013
May 2013   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01225263
2010P000118
No
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
March 2013

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