Recruiting

Vitamin K

Sponsor:

Augusta University

Code:

NCT01972113

Conditions

Obesity

Insulin Resistance

Insulin Sensitivity

Prediabetes

Dyslipidemia

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Accepted

Interventions

Placebo-Control

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

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

Study Details

Brief 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

Study ID

NCT01972113

Start date

Sep, 2013

Status verified date

Nov, 2019

Completion date

Dec 30, 2020

Anticipated

Primary completion date

Aug 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo-Control

The placebo-control group will take one placebo softgel capsules every day for 8 weeks.

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.

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.

Interventions

Placebo-Control

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

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

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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Norman K Pollock, Ph.D.

706-721-5424npollock@augusta.edu

Celestine F Williams, M.S.

706-721-8553cewilliams@augusta.edu

Locations

Medical College of Georgia; Augusta University

Recruiting

Augusta, Georgia, United States, 30909

Principal Investigator:

Norman K Pollock, Ph.D.

More Information

Sponsor

Augusta University

Last update posted

Nov 19, 2019

Last verified

Nov, 2019

Keywords

  • Vitamin K
  • Vitamin K2
  • Menaquinone-7
  • Osteocalcin
  • Children
  • Obesity
  • Insulin resistance
  • Insulin sensitivity
  • Beta-cell function
  • Prediabetes
  • Matrix Gla protein
  • Arterial stiffness
  • Endothelial function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2019-11-19.