The clinical trial showed significant benefits from a combination of vitamin K2 and vitamin D supplementation on coronary artery calcification (CAC).
Kappa Bioscience AS (Oslo Norway), recently acquired by Balchem Corp. (New Hampton, NY), is unveiling the first cardiovascular-health clinical study on its K2Vital Delta vitamin K2 ingredient investigating coronary artery calcification (CAC). The two-year study was conducted by Odense University Hospital in Denmark, with results recently shared at the European Society of Cardiology Congress in Barcelona, Spain, this August. At November’s SupplySide West trade show in Las Vegas, Nutritional Outlook caught up with Kappa representatives to discuss the company’s landmark study.
The two-year, double-blinded, randomized, placebo-controlled multicenter trial was conducted on 304 male participants with an average age of 71 who did not have prior ischemic heart disease. The goal was to determine whether the combination of K2Vital Delta vitamin K2 and vitamin D had a protective effect on individuals at risk of coronary artery calcification, which is a strong predictor of acute myocardial infarction (heart attack) and cardiovascular mortality.
Study subjects were given 720 µg of K2Vital Delta, which is a “double-encapsulated” vitamin K2 ingredient, alongside 25 µg of vitamin D daily. The subjects were given CT scans at baseline and after 12 months and 14 months. They were evaluated in two subgroups: 1) low-risk (those with CAC scores less than 400 AU), and 2) high-risk (those with CAC scores equal to or greater than 400 AU). Subjects were also assessed for events such as acute myocardial infarction, revascularization, and all-cause mortality.
According to the company, at the end of the study, researchers found that among the group deemed to be at high risk of CAC at baseline, subjects who consumed the K2Vital Delta plus vitamin D had a CAC score that was significantly lower by the end of the study compared to that of a placebo group. According to the company, this means that “vitamin D + K2 showed a tendency to slow down the progression of coronary plaque.”
At the SupplySide West show, Lena Leder, PhD, manager of science and content for Kappa Bioscience, explained how vitamin K2 and vitamin D work in tandem. “Vitamin D comes along first to produce vitamin K–dependent proteins, which are inactive at that point. Then vitamin K comes into the picture to activate those K-dependent proteins. Carboxylation changes the structure of those proteins, and then they’re able to bind calcium and take it from the arteries and to the bones where they are needed,” she explained.
The study researchers are now working on the peer-review process for publication, the company says. Lindsay Cole, sales and business development manager, North America, Kappa Bioscience, added that this study shows that “Getting enough D3 is only half of the story. If you’re not also supplementing with K2, then all of the calcium and all of the D3 intake is really calcifying your body. And we have so many fortified foods now that have calcium and D3 in them. We’re overloading our systems, but we’re not taking enough K2 to ensure calcium is going into the bone mass where it belongs.”
Leder added that with this study, which is called the AVADEC study, “These positive discoveries signal an exciting advancement as this is the first clinical trial documenting effects directly on calcium deposits in the coronary arteries."