Statin/Vitamin D & Migraine Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin D Supplementation in Episodic and Chronic Tension-type Headache

NCT05860062

Chronic Tension-Type Headache

UNKNOWN NA

A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine

NCT01695460

Migraine According to International Headache Society (IHS) Criteria (ICHD-II)

COMPLETED PHASE3

The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine

NCT05449145

Episodic Migraine

UNKNOWN NA

Vitamin K2 Supplementation in Adult Episodic Migraine

NCT05943457

Migraine Headache Arterial Stiffness Vitamin K Deficiency

RECRUITING NA

Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache

NCT00203255

Migraine Headache

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Simvastatin and vitamin D

Participants in this arm will receive simvastatin + vitamin D.

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

simvastatin, 20 mg, twice daily for 6 months

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3, 1000 IU, twice daily for 6 months

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".

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Two placebo pills, taken twice daily for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simvastatin

simvastatin, 20 mg, twice daily for 6 months

Intervention Type DRUG

Vitamin D

Vitamin D3, 1000 IU, twice daily for 6 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Two placebo pills, taken twice daily for 6 months

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No