Vitamin K2 Supplementation in Adult Episodic Migraine

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSola Aoun Bahous, M.D. Ph.D.

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

Qualifiers

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

Treatments tested in this trial

  • Vitamin K2 or menaquinone-7
  • Placebo

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sola Aoun Bahous, M.D. Ph.D.

Lead sponsor

Lebanese American University

Sponsor institution

Lesaffre International

Collaborator

Omicron Pharmaceuticals

Collaborator