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Vitamin K2 Supplementation in Adult Episodic Migraine

NCT05943457 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-11-18

No results posted yet for this 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.

Conditions

  • Migraine Headache
  • Arterial Stiffness
  • Vitamin K Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin K2 or menaquinone-7

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

OTHER

Placebo

Placebo pills will be administered orally once daily for 6 months

Sponsors & Collaborators

  • Lesaffre International

    collaborator INDUSTRY

  • Omicron Pharmaceuticals

    collaborator INDUSTRY

  • Sola Aoun Bahous, M.D. Ph.D.

    lead OTHER

Principal Investigators

  • Sola Aoun Bahous, MD, PhD · Lebanese American University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05943457 on ClinicalTrials.gov