Statin/Vitamin D & Migraine Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rami Burstein, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01225263
First received: September 30, 2010
Last updated: December 17, 2015
Last verified: December 2015
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Migraine
Interventions: Drug: Simvastatin
Dietary Supplement: Vitamin D
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the greater Boston area. All study visits took place at Beth Israel Deaconess Medical Center (Boston, MA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.

Participant Flow for 2 periods

Period 1:   Weeks 1 to 12
    Simvastatin and Vitamin D     Placebo "Sugar Pill"  
STARTED     28     29  
COMPLETED     28     29  
NOT COMPLETED     0     0  

Period 2:   Weeks 13 to 24
    Simvastatin and Vitamin D     Placebo "Sugar Pill"  
STARTED     28     29  
COMPLETED     24     28  
NOT COMPLETED     4     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Simvastatin and Vitamin D Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
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
Total Total of all reporting groups

Baseline Measures
    Simvastatin and Vitamin D     Placebo     Total  
Number of Participants  
[units: participants]
  28     29     57  
Age, Customized  
[units: years]
Median (Inter-Quartile Range)
     
Age     40  
  (23 to 46)  
  28  
  (21 to 34)  
  33  
  (21 to 44)  
Gender  
[units: participants]
     
Female     27     25     52  
Male     1     4     5  
Race/Ethnicity, Customized  
[units: participants]
     
Non-Hispanic White     24     21     45  
Other     4     8     12  
Recorded Migraine Days/Past 3m, Median (Interquartile Range)  
[units: days]
Median (Inter-Quartile Range)
  25.5   (14.5 to 34.0)     18.0   (14.0 to 23.0)     20   (14.0 to 28.0)  



  Outcome Measures
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1.  Primary:   Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12   [ Time Frame: Weeks 1 to 12 ]

2.  Primary:   Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24   [ Time Frame: Weeks 13 to 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Catherine Buettner, MD MPH
Organization: BIDMC
phone: 617-754-9600
e-mail: cbuettne@bidmc.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rami Burstein, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01225263     History of Changes
Other Study ID Numbers: 2010P000118
Study First Received: September 30, 2010
Results First Received: December 17, 2015
Last Updated: December 17, 2015
Health Authority: United States: Food and Drug Administration