Statin/Vitamin D & Migraine Study

NCT01225263 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2016-01-26

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Rami Burstein

    lead OTHER

Principal Investigators

  • Catherine Buettner, MD, MPH · Beth Israel Deaconess Medical Center

  • Rami Burstein, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225263 on ClinicalTrials.gov