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

Summary

The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). 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. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.

Conditions

• Obesity
• Insulin Resistance
• Insulin Sensitivity
• Prediabetes
• Dyslipidemia
• Diabetes

Interventions

DIETARY_SUPPLEMENT

Placebo-Control

one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)

DIETARY_SUPPLEMENT

Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d)

one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks

DIETARY_SUPPLEMENT

High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)

one 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• Yale University

  collaborator OTHER

• Tufts University

  collaborator OTHER

• Augusta University

  lead OTHER

Principal Investigators

• Norman K Pollock, Ph.D. · Department of Medicine, Medical College of Georgia, Augusta University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2020-08-30

Completion

2020-12-30

Countries

• United States

Study Locations