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

This study is currently recruiting participants.
Verified September 2017 by Norman Pollock, Augusta University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01972113
First Posted: October 30, 2013
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Alabama at Birmingham
Yale University
Tufts University
Nattopharma ASA
Information provided by (Responsible Party):
Norman Pollock, Augusta University
October 24, 2013
October 30, 2013
October 2, 2017
September 2013
August 2018   (Final data collection date for primary outcome measure)
  • Change in insulin sensitivity [ Time Frame: 8 weeks ]
    The first primary aim is to determine if the vitamin K-induced changes in carboxylation of osteocalcin and matrix Gla protein effects insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a two-hour oral glucose tolerance test by using the oral glucose minimal model.
  • Change in beta-cell function [ Time Frame: 8 weeks ]
    The second primary aim is to determine if the vitamin K-induced changes in carboxylation of osteocalcin and matrix Gla protein effects beta-cell function 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 two-hour oral glucose tolerance test by using the oral C-peptide minimal model.
  • Change in insulin sensitivity [ Time Frame: 8 weeks ]
    The first primary aim is to determine if the vitamin K-induced change in carboxylation of osteocalcin effects insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a two-hour oral glucose tolerance test by using the oral glucose minimal model.
  • Change in beta-cell function [ Time Frame: 8 weeks ]
    The second primary aim is to determine if the vitamin K-induced change in carboxylation of osteocalcin effects beta-cell function 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 two-hour oral glucose tolerance test by using the oral C-peptide minimal model.
Complete list of historical versions of study NCT01972113 on ClinicalTrials.gov Archive Site
  • 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.
  • Changes in serum adipokine concentrations [ Time Frame: 8 weeks ]
    Adipokines leptin and adiponectin will be measured in fasting serum at baseline and 8 weeks to explore whether changes in serum adipokine concentrations are influenced by vitamin K2 supplementation.
  • 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.
  • 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.
  • Changes in serum lipid concentrations [ Time Frame: 8 weeks ]
    Fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol) will be taken at baseline and 8 weeks to explore whether changes in serum lipid are influenced by vitamin K2 supplementation.
  • 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.
  • Change in coagulation [ Time Frame: 8 weeks ]
    Coagulation-related parameters (i.e., activated thrombin and endogenous thrombin potential) will be assessed at baseline and 8 weeks to determine that vitamin K2 has no procoagulant effect.
  • Changes in serum adipokine concentrations [ Time Frame: 8 weeks ]
    Adipokines leptin and adiponectin will be measured in fasting serum at baseline and 8 weeks to explore whether changes in serum adipokine concentrations are influenced by vitamin K2 supplementation.
  • Effects of sex, race, bone age, and pubertal stage on changes in glucose metabolism (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.
Not Provided
Not Provided
 
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Obesity
  • Insulin Resistance
  • Insulin Sensitivity
  • Prediabetes
  • Dyslipidemia
  • Diabetes
  • 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
    Other Name: menaquinone-7
  • 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 Name: menaquinone-7
  • Placebo Comparator: Placebo-Control
    The placebo-control group will take one placebo softgel capsules every day for 8 weeks.
    Intervention: Dietary Supplement: Placebo-Control
  • 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.
    Intervention: Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d)
  • 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.
    Intervention: Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2018
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
Yes
Contact: Norman K Pollock, Ph.D. 706-721-5424 npollock@augusta.edu
Contact: Celestine F Williams, M.S. 706-721-8553 cewilliams@augusta.edu
United States
 
 
NCT01972113
611523 (Pro00000912)
Yes
Not Provided
Not Provided
Norman Pollock, Augusta University
Augusta University
  • University of Alabama at Birmingham
  • Yale University
  • Tufts University
  • Nattopharma ASA
Principal Investigator: Norman K Pollock, Ph.D. Department of Pediatrics, Medical College of Georgia, Augusta University
Augusta University
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP