Statin/Vitamin D & Migraine Study

Migraine Clinical Trial

Official title:

Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225263
• Other study ID #: 2010P000118
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2010
• Last updated: December 17, 2015
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rami Burstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12		Weeks 1 to 12	No
Primary	Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24		Weeks 13 to 24	No