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Migraine HeadacheViKEMNCT05943457

Vitamin K2 Supplementation in Adult Episodic Migraine

A study testing Vitamin K2 or menaquinone-7 in people with Migraine Headache and Arterial Stiffness, run by Sola Aoun Bahous, M.D. Ph.D. at 1 site in Lebanon.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vitamin K2 or menaquinone-7
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteLebanon
Study dates
6 Mar 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sola Aoun Bahous, MD, PhD contact

+9613259450

sola.bahous@lau.edu.lb

Cedric Mhaseb, MD contact

+96176489620

cedric.mhasseb@lau.edu

Lebanon1 site, 1 recruiting

  • Lebanese American University Medical Center - Rizk Hospital

    Beirut, Beirut, 11-3288

    Sola Aoun Bahous, M.D. Ph.D., +9613259450, sola.bahous@lau.edu.lb

    Recruiting

Other trials in Lebanon

About this study

Official title: Efficacy of 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.

Being tested
Vitamin K2 or menaquinone-7, Placebo
Keywords
Migraine, Arterial stiffness, Vitamin K deficiency, Migraine attack
Medical subject headings
Migraine Disorders, Vitamin K Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin K2 or menaquinone-7Dietary supplement

    Also called MenaQ7

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

  • PlaceboOther

    Placebo pills will be administered orally once daily for 6 months

Study groups in NCT05943457
Study groupRoleWhat they receive
Intervention (MK7) ArmExperimentalThis corresponds to the sub-group of subjects who will receive the supplement (vitamin K2 or Menaquinone-7).
Receives: Dietary Supplement: Vitamin K2 or menaquinone-7
Control ArmPlacebo comparatorThis corresponds to the sub-group of subjects who will receive placebo.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of monthly migraine days

    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.

    Measured: 6 months

Secondary outcomes (6)

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

    Measured: 6 months

  2. Changes from baseline in monthly severe migraine days.

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  6. Changes from baseline of arterial stiffness level.

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start6 Mar 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Migraine subjects will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943457
Sponsor's protocol ID
MK7-003
Acronym
ViKEM
Status last verified
Nov 2025
First submitted
5 Jul 2023
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 17381554

  • 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.

    PubMed 27247281

  • 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.

    PubMed 28167849

  • 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.

    PubMed 22169620

  • 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.

    PubMed 28756183

  • 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.

    PubMed 31769041

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin K2 or menaquinone-7 in people with Migraine Headache and Arterial Stiffness, run by Sola Aoun Bahous, M.D. Ph.D. at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sola Aoun Bahous, MD, PhD (+9613259450, sola.bahous@lau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of monthly migraine days (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05943457, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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