Back to resultsStatin/Vitamin D & Migraine Study
Primary Purpose
Migraine
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring Migraine disorders, Headache, Simvastatin, Vitamin D
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Simvastatin and vitamin D
Placebo "Sugar Pill"
Arm Description
Participants in this arm will receive simvastatin + vitamin D.
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".
Outcomes
Primary Outcome Measures
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01225263
Brief Title
Statin/Vitamin D & Migraine Study
Official Title
Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rami Burstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine disorders, Headache, Simvastatin, Vitamin D
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin and vitamin D
Arm Type
Experimental
Arm Description
Participants in this arm will receive simvastatin + vitamin D.
Arm Title
Placebo "Sugar Pill"
Arm Type
Placebo Comparator
Arm 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".
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
simvastatin, 20 mg, twice daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D3, 1000 IU, twice daily for 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Two placebo pills, taken twice daily for 6 months
Primary Outcome Measure Information:
Title
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
Time Frame
Weeks 1 to 12
Title
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
Time Frame
Weeks 13 to 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Buettner, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rami Burstein, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26418341
Citation
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.
Results Reference
derived
Learn more about this trial
Statin/Vitamin D & Migraine Study
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