Vitamin K2 Supplementation in Adult Episodic Migraine (ViKEM)

July 5, 2023 updated by: Sola Aoun Bahous, M.D. Ph.D.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Lebanon
      • Beirut, Lebanon, 11-3288
        • Lebanese American University Medical Center - Rizk Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (MK7) Arm
This corresponds to the sub-group of subjects who will receive the supplement (vitamin K2 or Menaquinone-7).
Dietary supplement: Vitamin K2 or menaquinone-7
Vitamin K2 (MK7) 360 mcg/day orally once daily for 6 months
Other Names:
  • MenaQ7
Placebo Comparator: Control Arm
This corresponds to the sub-group of subjects who will receive placebo.
Other: Placebo
Placebo pills will be administered orally once daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in the headache impact score (HIT-6) as compared to placebo.
Time Frame: 6 months
6 months
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.
6 months
Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo.
Time Frame: 6 months
6 months
Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo.
Time Frame: 6 months
6 months
Changes from baseline on the quality of life as measure by the EuroQoL compared to placebo.
Time Frame: 6 months
6 months
Changes from baseline of arterial stiffness level.
Time Frame: 6 months
Changes of arterial stiffness level assessed by measuring the cfPWV using Complior Analyze.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Omicron Pharmaceuticals
Lesaffre International

Investigators

  • Principal Investigator: Sola Aoun Bahous, MD, PhD, Lebanese American University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK7-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

We have a plan to publish the study protocol as soon as possible.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine Headache

Clinical Trials on Vitamin K2 or menaquinone-7

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe