RecruitingNot Applicable

Vitamin K2 Supplementation in Adult Episodic Migraine

Lebanon160 participantsStarted 2024-03-06

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Successful completion of the migraine diary during the baseline evaluation period. Exclusion Criteria: * 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 * Patient who takes the following medications: * Ergotamine or Triptans \> 10 days per month * NSAIDs or paracetamol \> 15 days per month * Opioids more than 4 days per month * Patients on anticoagulants * Other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, post-herpetic neuralgia…) * History of hypersensitivity to the vitamin K2 * History of soy protein, cheese, eggs and meat allergy * History of thrombotic events * Diagnosed coagulopathy or any condition related to coagulation * Cardiovascular event in the past month * Current or planned pregnancy * Lactation * Inability to tolerate oral medications * Known intestinal ma…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes of monthly migraine days

Timeframe: 6 months

Trial details

NCT IDNCT05943457

SponsorSola Aoun Bahous, M.D. Ph.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Sola Aoun Bahous, MD, PhD

+9613259450 sola.bahous@lau.edu.lb

View on ClinicalTrials.gov More Migraine Headache trials