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: July 16, 2014
Last verified: July 2014
  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:


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 2015
Estimated Primary Completion Date: May 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 16, 2014
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 July 23, 2014