Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc for insulin resistance, prediabetes & type 2 diabetes.

Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials.

It had three arms (groups): Placebo-Control (placebo comparator), one (active comparator) and one (active comparator).

The placebo-control group will take two placebo softgel capsules every day for 8 weeks.

The registry classes the interventions as dietary supplement.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy adults between 18 and 65 years old. Subject understands the study protocol and agrees to comply with it. Informed Consent Form signed by the subject.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: subjects using vitamin supplements containing vitamin k; subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders; subjects presenting chronic degenerative and/or inflammatory diseases.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-02 with completion listed for 2020-06-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change in insulin sensitivity (time frame: Change from baseline in insulin sensitivity at 8 weeks). Change in beta-cell function (time frame: Change from baseline in beta-cell function at 8 weeks).

It also tracked 4 secondary outcomes, for example Change in prothrombin time (PT), Change in activated partial thromboplastin time (aPTT), Change in arterial stiffness (PWV) and Change in endothelial function (FMD).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 30 people with insulin resistance, prediabetes & type 2 diabetes.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, Insulin resistance, prediabetes & type 2 diabetes research.