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

November 18, 2019 updated by: Norman Pollock, Augusta University

Vitamin K and Glucose Metabolism in Children at Risk for Diabetes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Medical College of Georgia; Augusta University
        • Principal Investigator:
          • Norman K Pollock, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
  • Subjects receiving corticosteroid treatment
  • Subjects using oral anticoagulants
  • Subjects with a history of soy allergy
  • Subjects who have participated in a clinical study more recently than one month before the current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo-Control
The placebo-control group will take one placebo softgel capsules every day for 8 weeks.
Dietary supplement: Placebo-Control
one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
Active Comparator: Low-Dose Vitamin K2 (45 mcg/d)
The low-dose vitamin K2 group will take one 45-mcg vitamin K2 softgel capsule and one placebo softgel capsule every day for 8 weeks.
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
Other Names:
  • menaquinone-7
Active Comparator: High-Dose Vitamin K2 (90 mcg/d)
The high-dose vitamin K2 group will take one 90-mcg vitamin K2 softgel capsules every day 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
Other Names:
  • menaquinone-7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum lipid concentrations
Time Frame: 8 weeks
To determine if vitamin K supplementation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner.
8 weeks
Change in insulin sensitivity
Time Frame: 8 weeks
To determine if vitamin K supplementation improves insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour glucose tolerance test by using the oral glucose minimal model.
8 weeks
Change in beta-cell function
Time Frame: 8 weeks
To determine if vitamin K supplementation improves insulin sensitivity in a dose-dependent manner. Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a 2-hour glucose tolerance test by using the oral C-peptide minimal model.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in coagulation
Time Frame: 8 weeks
Coagulation-related parameters (i.e., prothrombin time and activated partial thromboplastin time) will be assessed at baseline and 8 weeks to assess clotting function.
8 weeks
Change in arterial stiffness (pulse wave velocity)
Time Frame: 8 weeks
Arterial stiffness, as measured by pulse wave velocity (PWV), will be assessed at baseline and 8 weeks to explore whether change in arterial stiffness is influenced by vitamin K2 supplementation.
8 weeks
Change in endothelial function (Flow-mediated dilation)
Time Frame: 8 weeks
Endothelial function, as measured by flow-mediated dilation (FMD), will be assessed at baseline and 8 weeks to explore whether change in endothelial function is influenced by vitamin K2 supplementation.
8 weeks
Effects of sex, race, bone age, and pubertal stage on changes in glucosemetabolism (insulin sensitivity and beta-cell function)
Time Frame: 8 weeks
Moderation effects of sex, race, bone age, and pubertal stage in the associations of vitamin K-induced changes in carboxylation of osteocalcin on markers of glucose metabolism will be determined.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

Yale University
University of Alabama at Birmingham
Tufts University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

August 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 611523 (Pro00000912)
  • 16GRNT31090037 (Other Grant/Funding Number: American Heart Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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