An interventional study of Vitamin K2 or menaquinone-7 and Placebo in Migraine Headache, Arterial Stiffness and Vitamin K Deficiency, sponsored by Sola Aoun Bahous, M.D. Ph.D.. Recruiting at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Sola Aoun Bahous, M.D. Ph.D. · Not applicable, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 160 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Sola Aoun Bahous, M.D. Ph.D. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient who takes the following medications:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This corresponds to the sub-group of subjects who will receive placebo.
Other: Placebo
Vitamin K2 (MK7) 360 mcg/day orally once daily for 6 months
Also known as: MenaQ7
Placebo pills will be administered orally once daily for 6 months
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.
Time frame: 6 months
Changes from baseline in the headache impact score (HIT-6) as compared to placebo.
Time frame: 6 months
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.
Time frame: 6 months
Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo.
Time frame: 6 months
Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo.
Time frame: 6 months
Changes from baseline on the quality of life as measure by the EuroQoL compared to placebo.
Time frame: 6 months
Changes from baseline of arterial stiffness level.
Changes of arterial stiffness level assessed by measuring the cfPWV using Complior Analyze.
Time frame: 6 months
Plan to share: Yes
Supporting information: Study protocol
Time frame: We have a plan to publish the study protocol as soon as possible.
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