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NCT Number: NCT05943457

Vitamin K2 Supplementation in Adult Episodic Migraine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lebanese American University Medical Center - Rizk Hospital

Beirut, 11-3288, Lebanon

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+9613259450

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K2 or menaquinone-7

Dietary Supplement

Vitamin K2 (MK7) 360 mcg/day orally once daily for 6 months

Other names: MenaQ7

Placebo

Other

Placebo pills will be administered orally once daily for 6 months

Primary outcomes

  1. Changes of monthly migraine days

    Time frame: 6 months

    Effect of Vitamin K2 supplementation on the changes from baseline in monthly migraine days as compared to placebo. This will be assessed clinically using a questionnaire to be administered at the start, monthly, and at the end of the study (6 months) about frequency and number of migraine days per month.

Secondary outcomes

  1. Changes from baseline in the headache impact score (HIT-6) as compared to placebo.

    Time frame: 6 months

  2. Changes from baseline in monthly severe migraine days.

    Time frame: 6 months

    Changes from baseline in monthly severe migraine days as defined by a visual analogue scale rating above 7, as compared to placebo.

  3. Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo.

    Time frame: 6 months

  4. Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo.

    Time frame: 6 months

  5. Changes from baseline on the quality of life as measure by the EuroQoL compared to placebo.

    Time frame: 6 months

  6. Changes from baseline of arterial stiffness level.

    Time frame: 6 months

    Changes of arterial stiffness level assessed by measuring the cfPWV using Complior Analyze.

Study contacts

Contact information is provided by the study sponsor or research team.

Cedric Mhaseb, MD

CONTACT

[email protected]

+96176489620

Sola Aoun Bahous, MD, PhD

CONTACT

[email protected]

+9613259450

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Lesaffre International
  • Omicron Pharmaceuticals

Registry information

Official study title

Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine

Acronym: ViKEM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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