Migraine
Conditions
Keywords
Migraine disorders, Headache, Simvastatin, Vitamin D
Brief summary
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.
Interventions
DRUGSimvastatin
simvastatin, 20 mg, twice daily for 6 months
DIETARY_SUPPLEMENTVitamin D
Vitamin D3, 1000 IU, twice daily for 6 months
OTHERPlacebo
Two placebo pills, taken twice daily for 6 months
Sponsors
Rami Burstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 | Weeks 1 to 12 |
| Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24 | Weeks 13 to 24 |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the greater Boston area. All study visits took place at Beth Israel Deaconess Medical Center (Boston, MA).
Pre-assignment details
Of 89 participants enrolled, 32 were excluded prior to randomization: 8 not interested; 8 lost to follow up; 7 had \<4 migraine days/mo; 4 had chronic daily headache; 2 daily opioid use; 1 chronic pain; 1 using a statin; 1 using a medication contraindicated with statin. The remaining 57 participants completed a 12-wk baseline and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Simvastatin and Vitamin D Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months. | 28 |
| Placebo Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months | 29 |
| Total | 57 |
Baseline characteristics
| Characteristic | Total | Simvastatin and Vitamin D | Placebo |
|---|---|---|---|
| Age, Customized Age | 33 years | 40 years | 28 years |
| Race/Ethnicity, Customized Non-Hispanic White | 45 participants | 24 participants | 21 participants |
| Race/Ethnicity, Customized Other | 12 participants | 4 participants | 8 participants |
| Recorded Migraine Days/Past 3m, Median (Interquartile Range) | 20 days | 25.5 days | 18.0 days |
| Sex: Female, Male Female | 52 Participants | 27 Participants | 25 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 28 | 10 / 29 |
| serious Total, serious adverse events | 0 / 28 | 1 / 29 |
Outcome results
Primary
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
Time frame: Weeks 13 to 24
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Simvastatin and Vitamin D | Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24 | -9.0 days |
| Placebo | Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24 | 3.0 days |
Primary
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
Time frame: Weeks 1 to 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Simvastatin and Vitamin D | Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 | -8.0 days |
| Placebo | Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 | 1.0 days |