Vitamin K2 Supplementation in Adult Episodic Migraine

Launched by SOLA AOUN BAHOUS, M.D. PH.D. · Jul 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a vitamin K2 supplement can help reduce the number of migraine attacks in adults. Researchers are interested in how vitamin K2 might also improve blood vessel health, as some studies suggest that people who experience migraines may have stiffer arteries. The trial will involve adults aged 18 and older who have been experiencing episodic migraines (meaning they have migraine attacks that come and go) for at least a year and have had these attacks 4 to 14 times a month over the past few months.

Participants in the study will be randomly assigned to receive either the vitamin K2 supplement or a placebo (a pill that looks the same but has no active ingredients) for six months. During this time, they will keep a diary of their migraines and undergo some tests to measure their blood vessel health at the beginning, middle, and end of the study. This trial is not yet recruiting participants, but if you or someone you know is interested, it’s important to meet the inclusion criteria and not have any of the specified conditions that would exclude participation.

Gender

ALL

Eligibility 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