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Vitamin K2 Supplementation in Adult Episodic Migraine (ViKEM)

Primary Purpose

Migraine Headache, Arterial Stiffness, Vitamin K Deficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Vitamin K2 or menaquinone-7
Placebo
Sponsored by
Sola Aoun Bahous, M.D. Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache focused on measuring Migraine, Arterial stiffness, Vitamin K deficiency, Migraine attack

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lebanese American University Medical Center - Rizk Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention (MK7) Arm

Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2023
Last Updated
July 5, 2023
Sponsor
Sola Aoun Bahous, M.D. Ph.D.
Collaborators
Lesaffre International, Omicron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05943457
Brief Title
Vitamin K2 Supplementation in Adult Episodic Migraine
Acronym
ViKEM
Official Title
Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sola Aoun Bahous, M.D. Ph.D.
Collaborators
Lesaffre International, Omicron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache, Arterial Stiffness, Vitamin K Deficiency
Keywords
Migraine, Arterial stiffness, Vitamin K deficiency, Migraine attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients, investigators, and analysts will remain blind to the identity of the treatment from the time of randomization until the time of unblinding. The identity of the treatment will be concealed by using placebo pills that are identical in appearance, color, odor and packaging. Unblinding will only occur in the case of a medical emergency and at the conclusion of the study.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (MK7) Arm
Arm Type
Experimental
Arm Description
This corresponds to the sub-group of subjects who will receive the supplement (vitamin K2 or Menaquinone-7).
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
This corresponds to the sub-group of subjects who will receive placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2 or menaquinone-7
Other Intervention Name(s)
MenaQ7
Intervention Description
Vitamin K2 (MK7) 360 mcg/day orally once daily for 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pills will be administered orally once daily for 6 months
Primary Outcome Measure Information:
Title
Changes of monthly migraine days
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes from baseline in the headache impact score (HIT-6) as compared to placebo.
Time Frame
6 months
Title
Changes from baseline in monthly severe migraine days.
Description
Changes from baseline in monthly severe migraine days as defined by a visual analogue scale rating above 7, as compared to placebo.
Time Frame
6 months
Title
Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo.
Time Frame
6 months
Title
Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo.
Time Frame
6 months
Title
Changes from baseline on the quality of life as measure by the EuroQoL compared to placebo.
Time Frame
6 months
Title
Changes from baseline of arterial stiffness level.
Description
Changes of arterial stiffness level assessed by measuring the cfPWV using Complior Analyze.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sola Aoun Bahous, MD, PhD
Phone
+9613259450
Email
sola.bahous@lau.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Chadia Haddad, PhD
Phone
+9613240119
Email
chadia_9@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sola Aoun Bahous, MD, PhD
Organizational Affiliation
Lebanese American University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lebanese American University Medical Center - Rizk Hospital
City
Beirut
ZIP/Postal Code
11-3288
Country
Lebanon
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sola Aoun Bahous, M.D. Ph.D.
Phone
+9613259450
Email
sola.bahous@lau.edu.lb

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
We have a plan to publish the study protocol as soon as possible.
Citations:
PubMed Identifier
17381554
Citation
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.
Results Reference
background
PubMed Identifier
27247281
Citation
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. Erratum In: BMJ. 2016 Jun 17;353:i3411.
Results Reference
background
PubMed Identifier
28167849
Citation
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.
Results Reference
background
PubMed Identifier
22169620
Citation
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.
Results Reference
background
PubMed Identifier
28756183
Citation
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.
Results Reference
background
PubMed Identifier
31769041
Citation
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.
Results Reference
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Vitamin K2 Supplementation in Adult Episodic Migraine

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