A new study protocol has been published detailing a clinical trial which will take place in Lebanon, exploring potential impacts of vitamin K2 supplementation for migraine sufferers. Gnosis by Lesaffre is supporting the study, which will administer 360 mcg of MenaQ7 Vitamin K2 as MK-7 to the experimental arm. The trial is being run in conjunction with Omicron Pharmaceuticals.
 
More than 10% of the global population is estimated to be affected by migraines, which are three times more common in women than men. The World Health Organization (WHO) ranks migraine as the fifth highest cause of years lost due to disability, with approximately 38% of migraine patients requiring preventative therapy. Unfortunately, therapies currently available, which are not migraine-specific, offer limited effectiveness and significant adverse effects.
 
Lebanese researchers have been exploring the potential of vitamin K2 as a potential therapy based on its impact on arterial stiffness, beginning first with a trial in 2019 which linked migraine incidence with worse indices of arterial stiffness, as well as markers of vitamin K2 deficiency, compared to the general population.
 
In the new study, “Efficacy of K2 Supplementation in Adult Episodic Migraine,” migraine patients between the ages of 18 and 45 will be recruited from the neurology clinic at the Lebanese American University Medical Center-Rizk Hospital in Lebanon, with the purpose of testing if K2 supplementation has a preventive role in migraine attacks, with arterial stiffness as a secondary outcome.
 
“Several mechanisms have been suggested to explain the condition and its linkage to other comorbidities, including generalized anxiety disorders, restless leg syndrome, chronic pain syndromes, and more serious cardiovascular diseases, but studies have failed to explain with certainty the increased cardiovascular risk and reasons behind augmented large arterial stiffness in patients with migraine,” said Sola Aoun Bahous, MD, PhD, MHPE, lead researcher, dean, and professor of medicine at Gilbert & Rose-Marie Chagoury School of Medicine, Lebanese American University. “Vitamin K2 is a fat-soluble vitamin that serves as an essential cofactor in the activation of matrix Gla protein (MGP) in the vascular smooth muscle cell, with vitamin K deficiency resulting in impaired MGP carboxylation and, subsequently, an increased calcification effect. Circulating concentrations of dephosphorylated uncarboxylated MGP [dp-ucMGP] are indicative of vitamin K deficiency and associated with the extent of vascular calcification, arterial stiffness, and development of cardiovascular events in specific populations.”
 
“Our 2019 study presented a plausible hypothesis that vitamin K2 deficiency in patients with migraine with aura may contribute to the increased cardiovascular risk observed in this patient population,” she continued. “Furthermore, patients with migraine in general have more vitamin K2 deficiency than their matched controls. With this new study, we hope to explore whether supplementation with vitamin K2 confers cardiovascular protection and reduces migraine episodes.”
 
In the new study, patients in the vitamin K2 and placebo groups will be tested for arterial stiffness at baseline, at three months, and at the end of the study. Clinical and standardized questionnaires will be used to assess the frequency of migraines throughout the study. The endpoints are assessment of changes in monthly migraine days as compared to baseline as well as changes in arterial stiffness as compared to baseline.
 
“This new study presents a new wave of insight for migraine sufferers, and Gnosis is excited to play a role in these efforts,” said Sophie Legrain-Raspaud, director of R&A at Gnosis by Lesaffre. “Our research has identified and demonstrated the cardio-protective mechanism of vitamin K2, and new research is beginning to surface linking this mechanism to having an impact beyond just heart health, including brain and vision support. We share the researchers’ enthusiasm that this new study could present strong grounds for discussing this potential relationship with migraine patients to guide their dietary habits or supplementation routines toward improving their vitamin K2 status.”
 
“We have seen the benefits of MenaQ7 on vascular stiffness since we launched it in the market in 2010,” said Hisham Ramadan, CEO of Omicron. “We have no doubt that MenaQ7 will help migraine patients since they fall under the same category. MenaQ7 has been shown to reduce arterial stiffness significantly, as well as it help substantially those patients who suffered from aortic valve calcification, coronary artery calcification, and chronic kidney disease.”