Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)

What Was Tested

In this not phased trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc for insulin resistance, prediabetes & type 2 diabetes.

However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk.

Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism.

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

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 8 years up to 17 years.

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

Examples of who could join: Age 8 to 17 years. Body mass index equal to or greater than 85th percentile for age and sex. Subject and parent/guardian understands the study protocol and agrees to comply with it. Informed Consent Form signed by the parent/guardian and assent signed by the subject.

The full record lists 4 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

Design: 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.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

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

It started in 2016-10 with completion listed for 2020-12-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Change in serum lipid concentrations (time frame: 8 weeks). Change in insulin sensitivity (time frame: 8 weeks). Change in beta-cell function (time frame: 8-weeks).

It also tracked 3 secondary outcomes, for example Change in coagulation, Change in arterial stiffness (pulse wave velocity) and Change in endothelial function (flow-mediated dilation).

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.