Vitamin K2 Supplementation in Adult Episodic Migraine

Phase

N/A

Condition

Acute Pain

Migraine (Adult)

Pain

Treatment

Placebo

Vitamin K2 or menaquinone-7

Clinical Study ID

NCT05943457

MK7-003

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adults aged 18 years or above
History of episodic migraine with or without aura since > 12 months according to theICHD-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 ofassessment.
Successful completion of the migraine diary during the baseline evaluation period.

Exclusion

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 (Sodiumvalproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine,Verapamil, Lisinopril, Candesartan)
Patients who have been on any of the previously listed medications within 3 monthsof 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 peripheralneuropathy, 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

Study Design