Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05943457 | NOT YET RECRUITING | Migraine Headache

Vitamin K2 Supplementation in Adult Episodic Migraine
Sponsor:

Sola Aoun Bahous, M.D. Ph.D.

Information provided by (Responsible Party):

Sola Aoun Bahous, M.D. Ph.D.

Brief 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.

Condition or disease

Migraine Headache

Arterial Stiffness

Vitamin K Deficiency

Intervention/treatment

Vitamin K2 or menaquinone-7

Placebo

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : QUADRUPLE
Masking Description : Patients, investigators, and analysts will remain blind to the identity of the treatment from the time of randomization until the time of unblinding. The identity of the treatment will be concealed by using placebo pills that are identical in appearance, color, odor and packaging. Unblinding will only occur in the case of a medical emergency and at the conclusion of the study.
Primary Purpose : TREATMENT
Official Title : Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine
Actual Study Start Date : 2023-09
Estimated Primary Completion Date : 2024-09
Estimated Study Completion Date : 2024-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Vitamin K2 Supplementation in Adult Episodic Migraine

Location Details

NCT05943457

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Lebanon,

Lebanese American University Medical Center - Rizk Hospital

Beirut, Lebanon, 11-3288