ViKEM: Vitamin K2 Supplementation in Adult Episodic Migraine

Sponsor

Sola Aoun Bahous, M.D. Ph.D. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05943457

Collaborator

Lesaffre International (Industry), Omicron Pharmaceuticals (Industry)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Headache Arterial Stiffness Vitamin K Deficiency	Dietary Supplement: Vitamin K2 or menaquinone-7 Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Migraine subjects will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months.Migraine subjects will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes of monthly migraine days [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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