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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin and vitamin D | Experimental | Participants in this arm will receive simvastatin + vitamin D. |
|
| Placebo "Sugar Pill" | Placebo Comparator | 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". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | simvastatin, 20 mg, twice daily for 6 months |
| |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Buettner, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Rami Burstein, PhD | Beth Israel Deaconess Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26418341 | Derived | Buettner C, Nir RR, Bertisch SM, Bernstein C, Schain A, Mittleman MA, Burstein R. Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial. Ann Neurol. 2015 Dec;78(6):970-81. doi: 10.1002/ana.24534. Epub 2015 Nov 13. |
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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 were recruited from the greater Boston area. All study visits took place at Beth Israel Deaconess Medical Center (Boston, MA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin and Vitamin D | Participants in this arm took Simvastatin 20 mg twice daily for 6 months plus Vitamin D3 1000 IU twice daily for 6 months. |
| FG001 | Placebo "Sugar Pill" | Participants in this arm took placebo pills, which looked like the Simvastatin and Vitamin D. Two placebo pills were taken twice daily for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Weeks 1 to 12 |
| |||||||||||||
| Weeks 13 to 24 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin and Vitamin D | Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 | Posted | Median | Inter-Quartile Range | days | Weeks 1 to 12 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin and Vitamin D | Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myositis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 1 participant in the placebo group had a creatine kinase (CK) level of 37,780 IU/L. On inquiry, the participant had been vigorously exercising while taking multiple stimulant-containing dietary supplements. The participant experienced full recovery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Buettner, MD MPH | BIDMC | 617-754-9600 | cbuettne@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Vitamin D |
| Dietary Supplement |
Vitamin D3, 1000 IU, twice daily for 6 months |
|
| Placebo | Other | Two placebo pills, taken twice daily for 6 months |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Recorded Migraine Days/Past 3m, Median (Interquartile Range) | Median | Inter-Quartile Range | days |
|
| Participants |
|
|
| Primary | Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24 | Posted | Median | Inter-Quartile Range | days | Weeks 13 to 24 |
|
|
|
| 0 |
| 28 |
| 5 |
| 28 |
| EG001 | Placebo | Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months | 1 | 29 | 10 | 29 |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia (without CK elevation) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Skin rash or itch | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |