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Completed

NCT Number: NCT01225263

Statin/Vitamin D & Migraine Study

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

simvastatin, 20 mg, twice daily for 6 months

Vitamin D

Dietary Supplement

Vitamin D3, 1000 IU, twice daily for 6 months

Placebo

Other

Two placebo pills, taken twice daily for 6 months

Primary outcomes

  1. Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12

    Time frame: Weeks 1 to 12

  2. Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24

    Time frame: Weeks 13 to 24

Sponsors and collaborators

Lead sponsor

Rami Burstein

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2010
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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