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Trial details
ViKEM
Current status:
Approved
|
Date registered:
06/02/2024
Trial version(s)
Current: 24/07/2023
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Main Information
Primary registry identifying number
LBCTR2023075403
Protocol number
MK7-003
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
24/07/2023
Primary sponsor
Sola Aoun Bahous
Primary sponsor: Country of origin
Lebanon
Public title
ViKEM
Acronym
Scientific title
Vitamin K2 Supplementation in Adult Episodic Migraine
Acronym
Brief summary of the study: English
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 migraines 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. Lab tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.
Brief summary of the study: Arabic
مكملات الفيتامينات هي خيار علاجي غير مستكشف للمرضى الذين يعانون من الصداع النصفي. أدركت العديد من الدراسات دور التغيرات الوعائية في تطور الصداع النصفي. تبين سابقاً أن للفيتامين K2 دوراً في تحسين صحة الأوعية الدموية من دون أثار جانبية سلبية مهمة أو تفاعل سلبي مع أدوية أخرى. أيضاً، تبين أن الأشخاص الذين يعانون من الصداع النصفي يعانون من نقص في مستوى فيتامين (ك) وارتباط مباشر بين هذا النقص وزيادة تصلب الشرايين. تهدف دراستنا تقييم دور الفيتامين ك2 خلال ستة أشهرمن التناول في تحسين نوبات الصداع النصفي وتحسين صحة الأوعية الدموية عند مرضى تعاني من الصداع في المركز الطبي للجامعة اللبنانية الأميركية - مستشفى رزق (LAUMC-RH). يتم قياس صحة الأوعية الدموية عن طريق تقنية غير غازية تقيس سرعة موجة النبض (Pulse Wave Velocity) بين الشريان الفخذي (Femoral Artery) و الشريان السباتي(Carotid Artery) بهدف معرفة مدى سرعة تدفق الدم في الشرايين الرئيسية و أيضاً عن طريق قياس معدل الفيتامين K2 في الدم و معدل بروتينات أخرى تدل على صحة الشرايين في الدم. سنقوم بتقييم أيضا دور عوامل أخرى قد تكون مرتبطة بقياس سرعة موجة النبض أو معدل فيتامين K2 في الدم عند هؤلاء المرضى. نأمل في تسجيل حوالي 120 مشارك في هذه الدراسة. مدة الدراسة: • تستغرق هذه الدراسة حوالي ٦ أشهر.
Health conditions/problem studied: Specify
Episodic migraine headache among adult subjects.
Interventions: Specify
Vitamin K2 (MenaQ7) vs. Placebo for 6 months
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion criteria: adults subjects, 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.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
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, patients who take 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 oral vitamin K antagonists, other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, postherpetic neuralgia…), history of hypersensitivity to the vitamin K2, history of soy protein allergy, history of thrombotic events, diagnosed coagulopathy, 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. or acute illness in the past month.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
N/A
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Lebanon
Name of IMP
MenaQ7
Type of IMP
Others
Type of IMP: Specify
Vitamin
Pharmaceutical class
Supplement/Vitamin - Menaquinone
Therapeutic indication
Episodic migraine headache
Therapeutic benefit
Possible improvement in migraine attacks and arterial stiffness.
Biospecimen retention
None retained
Biospecimen description
Blood samples will be drawn for tests. urine will be collected for analysis.
Target sample size
160
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
03/09/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
02/09/2024
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
We will be ready to share data upon request.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
ClinicalTrials.gov
NCT05943457
Sources of Monetary or Material Support
Name
Lesaffre International
Secondary Sponsors
Name
Omicron Pharmaceuticals
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Sola
Aoun Bahous
Lebanese American University
Lebanon
+9613259450
sola.bahous@lau.edu.lb
Lebanese American University
Scientific
Sola
Aoun Bahous
Lebanese American University
Lebanon
+9613259450
sola.bahous@lau.edu.lb
Lebanese American University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Lebanese American University Medical Center-Rizk Hospital
Sola Aoun Bahous
Nephrology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
02/12/2022
Joseph Stephan
joseph.stephan@lau.edu.lb
+96176660166
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Episodic migraine
Migraine (G43)
Migraine
Interventions
Intervention
Description
Keyword
Menaquinone
360 mcg/d of menaquinone-7 (MenaQ7; NattoPharma, Hovik, Norway) for 6 months.
MenaQ7
Primary Outcomes
Name
Time points
Measure
Changes of monthly migraine days
6 months
aquestionnaire to be administered at the start, monthly, and at the end of the study (6months) about frequency and number of migraine days per month.
Key Secondary Outcomes
Name
Time points
Measure
Changes from baseline in the headache impact score
3 & 6 months
HIT-6
Changes from baseline in monthly severe migraine days
3 & 6 months
visual analogue rating scale
Changes from baseline on the modifi ed migraine disability assessment
3 & 6 months
MIDAS
Changes from baseline on the modified migraine physical function impact diary
3 & 6 months
MPFID
Changes from baseline on the quality of life
3 & 6 months
EuroQoL
Changes of arterial stiffness level
3 & 6 months
cfPWV
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial