Vitamin K2 Clinical Trial Announced

The study will examine the impact of the combination of an oral anti-diabetic with vitamins K2 and D3 on various diabetic parameters, including quality-of-life.

research

Marcq-en-Baroeul, France and East Brunswick, NJ—Gnosis by Lesaffre shared the news that a study protocol has been published on ClinicalTrials.gov (NCT05417880) detailing a trial initiated by Gnosis by Lesaffre partner Scotmann Pharmaceuticals, Pakistan. The large-scale, multi-centered study will examine the impact of the combination of the oral anti-diabetic Empagliflozin with vitamins K2 and D3 on various diabetic parameters, including quality-of-life. Scotmann uses Gnosis by Lesaffre’s clinically validated vitamin K2 MK7 from natural fermentation.

The VETA Trial

Called the VETA Trial (Vitamin D, K2 plus Empagliflozin combination in Type Two Diabetes Mellitus), this six-month prospective, randomized, controlled, open-label, multi-center trial is conducted in collaboration with the University of Health Sciences Lahore (Pakistan) and the Pakistan Society of Internal Medicine. The study will enroll 340 participants, aged 40-60 years, who have had type 2 diabetes mellitus (T2DM) for at least 10 years. Find details of the research and main goals here.

“The idea is to follow the holistic approach guidelines for the management of T2DM,” said Dr. Syeda Saba Alsam, Head of Medical Affairs and Research with Scotmann Pharmaceuticals, Pakistan, in a press release. Dr. Syeda Saba Alsam noted that baseline screening of serum 25(OH)D3 levels would be done on all patients. “Since Vitamin D deficiency is highly prevalent in this cohort and a typical Pakistani diet lacks Vitamin K2, we are exploring the potential beneficial effects of these two micronutrients in Diabetic patients.”

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Putting the need for such research in perspective, Gnosis by Lesaffre shared that there were 437.9 million prevalent cases of type 2 diabetes globally in 2019, and cases represents a 49% increase since 1990.

“While treatment is crucial for diabetes, the proper nutrient intake is also important for this group of patients. Deficiency of vitamin D is globally recognized; however, the research suggests that vitamin D3 should be combined with vitamin K2 for synergistic impact. Further, it has been shown that vitamin K2 supplementation can effectively improve clinical features of diabetes,” says Sophie Legrain, Gnosis by Lesaffre Director of R&D, pointing to research showing vitamin K2 intake, specifically, produced a 7% reduction in T2DM risk with each 10mcg increment. “It is exciting to see our partner exploring the impact K2 and D3 could have for patients adding it to their therapy.”