About this trial
Migraine is a debilitating illness and a major cause of disability in the world. It is highly prevalent, especially among women. Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. Several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. Vitamin K2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix Gla protein (MGP). Supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. Therefore, vitamin K2 supplementation could serve a potential role in migraine patients. The purpose of the study is to test the effect of vitamin K2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. The population will be recruited from the neurology clinic at LAU Medical Center-Rizk Hospital and will constitute of adult patients. They will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months. Laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or above
History of episodic migraine with or without aura since > 12 months according to the ICHD-3 criteria.
Migraine frequency from 4-14 days per month over the 3 months prior to screening.
Migraine frequency from 4-14 days per month during the baseline period of assessment.
Disqualifiers
Migraine patients with superimposed tension type or other forms of primary headaches
Patients who are currently on any of the migraine prophylactic treatments (Sodium valproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine, Verapamil, Lisinopril, Candesartan)
Patients who have been on any of the previously listed medications within 3 months of screening
Ergotamine or Triptans > 10 days per month
Trial design
Parallel
Treatments tested in this trial
Vitamin K2 or menaquinone-7
Dietary supplementVitamin K2 (MK7) 360 mcg/day orally once daily for 6 months
Placebo
Other interventionPlacebo pills will be administered orally once daily for 6 months
Treatment groups
Trial outcomes
Primary outcomes
Changes of monthly migraine days
Effect of Vitamin K2 supplementation on the changes from baseline in monthly migraine days as compared to placebo. This will be assessed clinically using a questionnaire to be administered at the start, monthly, and at the end of the study (6 months) about frequency and number of migraine days per month.
Secondary outcomes
Changes from baseline in the headache impact score (HIT-6) as compared to placebo.
Changes from baseline in monthly severe migraine days.
Changes from baseline in monthly severe migraine days as defined by a visual analogue scale rating above 7, as compared to placebo.
Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo.
Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo.
Sponsors and contacts
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Sola Aoun Bahous, M.D. Ph.D.
Lead sponsor
Lebanese American University
Sponsor institution
Lesaffre International
Collaborator
Omicron Pharmaceuticals
Collaborator