Actively Recruiting
Vitamin K2 Supplementation in Adult Episodic Migraine
Led by Sola Aoun Bahous, M.D. Ph.D. · Updated on 2025-11-18
160
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
S
Sola Aoun Bahous, M.D. Ph.D.
Lead Sponsor
L
Lesaffre International
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vitamin K2 Supplementation in Adult Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or above
- History of episodic migraine with or without aura for more than 12 months according to ICHD-3 criteria
- Migraine frequency of 4 to 14 days per month over the 3 months prior to screening
- Migraine frequency of 4 to 14 days per month during the baseline assessment period
- Successful completion of migraine diary during baseline evaluation
You will not qualify if you...
- Migraine patients with additional tension-type or other primary headaches
- Currently using migraine prophylactic treatments (Sodium valproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine, Verapamil, Lisinopril, Candesartan)
- Use of the above medications within 3 months before screening
- Frequent use of Ergotamine or Triptans more than 10 days per month
- Use of NSAIDs or paracetamol more than 15 days per month
- Use of opioids more than 4 days per month
- Use of anticoagulants
- Presence of other active chronic pain conditions (fibromyalgia, painful peripheral neuropathy, post-herpetic neuralgia)
- History of hypersensitivity to vitamin K2
- Allergies to soy protein, cheese, eggs, or meat
- History of thrombotic events
- Diagnosed coagulopathy or coagulation-related conditions
- Cardiovascular event within 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lebanese American University Medical Center - Rizk Hospital
Beirut, Beirut, Lebanon, 11-3288
Actively Recruiting
Research Team
S
Sola Aoun Bahous, MD, PhD
CONTACT
C
Cedric Mhaseb, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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