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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Migraine
 Drug: Simvastatin
Dietary Supplement: Vitamin D
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Migraine frequency [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Frequency of migraine attacks


Secondary Outcome Measures:
  • Duration of Migraine [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Duration of each migraine attack


Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin and vitamin D
Participants in this arm will receive simvastatin + vitamin D.
 Drug: Simvastatin
simvastatin, 20 mg, twice daily for 6 months
Dietary Supplement: Vitamin D
Vitamin D3, 1000 IU, twice daily for 6 months
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".
 Other: Placebo
Two placebo pills, taken twice daily for 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225263

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Rami Burstein
Investigators
Principal Investigator: Catherine Buettner, MD, MPH Beth Israel Deaconess Medical Center
Study Director: Rami Burstein, PhD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Rami Burstein, Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01225263     History of Changes
Other Study ID Numbers: 2010P000118
Study First Received: September 30, 2010
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
Migraine disorders
Headache
Simvastatin
Vitamin D

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamin D
Ergocalciferols
Vitamins
Simvastatin
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Micronutrients
Growth Substances
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013