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

What Was Tested

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

Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk.

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

The placebo-control group will take one 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 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. BMI less than 85th percentile for age and gender. 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

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

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

Neither the insulin resistance, prediabetes & type 2 diabetes participants nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

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

It started in 2013-09 with completion listed for 2020-08-30.

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 4 secondary outcomes, for example Change in coagulation, Change in arterial stiffness (pulse wave velocity), Change in endothelial function (Flow-mediated dilation) and Effects of sex, race, bone age, and pubertal stage on changes in glucosemetabolism (insulin sensitivity and beta-cell function).

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.