Vitamin K2 for adults with episodic migraine
Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine
This will test whether vitamin K2 supplements can reduce how often adults with episodic migraine have attacks and lower arterial stiffness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lebanese American University Academic / other |
| Locations | 1 site (Beirut, Beirut) |
| Trial ID | NCT05943457 on ClinicalTrials.gov |
What this trial studies
Adults with episodic migraine who meet eligibility will be recruited from the neurology clinic at Lebanese American University Medical Center–Rizk Hospital and given either vitamin K2 (menaquinone‑7) or a placebo. Participants will complete a baseline migraine diary and be followed to compare changes in migraine attack frequency and measures of arterial stiffness. The trial targets people with 4–14 migraine days per month and excludes those on standard migraine prevention or with other primary headache disorders. Vascular outcomes are motivated by prior findings that vitamin K2 can reduce arterial stiffness in other patient groups, while migraine outcomes address a largely under‑explored nutritional approach.
Who should consider this trial
Good fit: Adults aged 18 or older with episodic migraine (4–14 migraine days per month for at least 12 months, meeting ICHD‑3 criteria) who complete the baseline diary and are not using listed prophylactic medications are ideal candidates.
Not a fit: Patients with chronic migraine (>14 days/month), mixed primary headache disorders, those on migraine preventive drugs, or with medication overuse are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, vitamin K2 could offer a low‑cost option to lower migraine frequency and improve vascular health in affected adults.
How similar studies have performed: Prior studies have shown vitamin K2 can improve arterial stiffness and vascular calcification in patients with end‑stage renal disease, but using vitamin K2 specifically to reduce migraine frequency is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 malabsorption or hypomotility syndromes * Atrial fibrillation * Active malignancy * Any acute illness in the past month
Where this trial is running
Beirut, Beirut
- Lebanese American University Medical Center - Rizk Hospital — Beirut, Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Sola Aoun Bahous, MD, PhD — Lebanese American University School of Medicine
- Study coordinator: Sola Aoun Bahous, MD, PhD
- Email: sola.bahous@lau.edu.lb
- Phone: +9613259450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.