Vitamin K2 Supplementation in Adult Episodic Migraine

NCT ID: NCT05943457

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2026-12-31

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.

Conditions

Migraine Headache; Arterial Stiffness; Vitamin K Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention (MK7) Arm

This corresponds to the sub-group of subjects who will receive the supplement (vitamin K2 or Menaquinone-7).

Group Type: EXPERIMENTAL

Vitamin K2 or menaquinone-7

Intervention Type: DIETARY_SUPPLEMENT

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

Control Arm

This corresponds to the sub-group of subjects who will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo pills will be administered orally once daily for 6 months

Interventions

Vitamin K2 or menaquinone-7

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo pills will be administered orally once daily for 6 months

Intervention Type: OTHER

Other Intervention Names

MenaQ7

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lesaffre International

INDUSTRY

Sponsor Role: collaborator

Omicron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

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

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sola Aoun Bahous, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lebanese American University School of Medicine

Locations

Lebanese American University Medical Center - Rizk Hospital

Beirut, Beyrouth, Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Sola Aoun Bahous, MD, PhD

Role: CONTACT

sola.bahous@lau.edu.lb

+9613259450

Cedric Mhaseb, MD

Role: CONTACT

cedric.mhasseb@lau.edu

+96176489620

Facility Contacts

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

Role: primary

sola.bahous@lau.edu.lb

+9613259450

References

Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.

Reference Type: BACKGROUND

PMID: 17381554 (View on PubMed)

Kurth T, Winter AC, Eliassen AH, Dushkes R, Mukamal KJ, Rimm EB, Willett WC, Manson JE, Rexrode KM. Migraine and risk of cardiovascular disease in women: prospective cohort study. BMJ. 2016 May 31;353:i2610. doi: 10.1136/bmj.i2610.

Reference Type: BACKGROUND

PMID: 27247281 (View on PubMed)

Mozos I, Stoian D, Luca CT. Crosstalk between Vitamins A, B12, D, K, C, and E Status and Arterial Stiffness. Dis Markers. 2017;2017:8784971. doi: 10.1155/2017/8784971. Epub 2017 Jan 12.

Reference Type: BACKGROUND

PMID: 28167849 (View on PubMed)

Westenfeld R, Krueger T, Schlieper G, Cranenburg EC, Magdeleyns EJ, Heidenreich S, Holzmann S, Vermeer C, Jahnen-Dechent W, Ketteler M, Floege J, Schurgers LJ. Effect of vitamin K2 supplementation on functional vitamin K deficiency in hemodialysis patients: a randomized trial. Am J Kidney Dis. 2012 Feb;59(2):186-95. doi: 10.1053/j.ajkd.2011.10.041. Epub 2011 Dec 9.

Reference Type: BACKGROUND

PMID: 22169620 (View on PubMed)

Mansour AG, Hariri E, Daaboul Y, Korjian S, El Alam A, Protogerou AD, Kilany H, Karam A, Stephan A, Bahous SA. Vitamin K2 supplementation and arterial stiffness among renal transplant recipients-a single-arm, single-center clinical trial. J Am Soc Hypertens. 2017 Sep;11(9):589-597. doi: 10.1016/j.jash.2017.07.001. Epub 2017 Jul 13.

Reference Type: BACKGROUND

PMID: 28756183 (View on PubMed)

Mansour AG, Ahdab R, Daaboul Y, Korjian S, Morrison DA, Hariri E, Salem M, El Khoury C, Riachi N, Aoun Bahous S. Vitamin K2 Status and Arterial Stiffness Among Untreated Migraine Patients: A Case-Control Study. Headache. 2020 Mar;60(3):589-599. doi: 10.1111/head.13715. Epub 2019 Nov 25.

Reference Type: BACKGROUND

PMID: 31769041 (View on PubMed)

Other Identifiers

MK7-003

Identifier Type: -

Identifier Source: org_study_id