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

NCT02366481 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-11-20

No results posted yet for this study

Summary

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. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.

DIETARY_SUPPLEMENT

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

One 90-mcg vitamin K2 softgel capsules (containing no vitamin K2) and one placebo softgel capsule everyday for 8 weeks.

DIETARY_SUPPLEMENT

High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)

Two 90-mcg vitamin K2 softgel capsules every 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 Pediatrics, Medical College of Georgia, Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2020-06-01
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366481 on ClinicalTrials.gov