Lebanese American University Medical Center - Rizk Hospital
Beirut, 11-3288, Lebanon
Location status: Recruiting
NCT Number: NCT05943457
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beirut, 11-3288, Lebanon
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vitamin K2 (MK7) 360 mcg/day orally once daily for 6 months
Other names: MenaQ7
Placebo pills will be administered orally once daily for 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Changes of arterial stiffness level assessed by measuring the cfPWV using Complior Analyze.
Contact information is provided by the study sponsor or research team.
Cedric Mhaseb, MD
CONTACT
Sola Aoun Bahous, MD, PhD
CONTACT
Sola Aoun Bahous, M.D. Ph.D.
Other
Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine
Acronym: ViKEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06459635
Brain Diseases, Central Nervous System Diseases
Madrid, Spain
View Trial DetailsNCT07348783
Brain Diseases, Bronchial Diseases
Huddinge, Sweden
View Trial DetailsNCT07476053
Brain Diseases, Central Nervous System Diseases
Tempe, Arizona, United States
View Trial DetailsNCT07022496
Brain Diseases, Central Nervous System Diseases
Cairo, Egypt
View Trial Details