NCT05943457Recruiting
Vitamin K2 Supplementation in Adult Episodic Migraine
Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 5 Jul 2023
- Start date
- 6 Mar 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Sola Aoun Bahous, M.D. Ph.D.
- Diseases
- Migraine
- NCT number
- NCT05943457
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 6 Mar 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Inability to tolerate oral medications
Other illness
- 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
- Known intestinal malabsorption or hypomotility syndromes
- Active malignancy
- Any acute illness in the past month
Lab values
- Patients who are currently on any of the migraine prophylactic treatments (Sodium valproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine, Verapamil, Lisinopril, Candesartan)
Other
- Migraine patients with superimposed tension type or other forms of primary headaches
- Cardiovascular event in the past month
- Current or planned pregnancy
- Lactation
- Atrial fibrillation
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lebanese American University Medical Center - Rizk Hospital Coordinator of this site? Confirm its status | Beirut | Lebanon | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.