Statin/Vitamin D & Migraine Study

Rami Burstein

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Other: Placebo; Dietary Supplement: Vitamin D; Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01225263

2010P000118

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 2 patient groups, including a placebo group

Simvastatin and vitamin D

Experimental group

Description:

Participants in this arm will receive simvastatin + vitamin D.

Treatment:

Dietary Supplement: Vitamin D

Drug: Simvastatin

Placebo "Sugar Pill"

Placebo Comparator group

Description:

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".

Treatment:

Other: Placebo