Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2013
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedNovember 19, 2019
November 1, 2019
7 years
October 24, 2013
November 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in serum lipid concentrations
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
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
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 Outcomes (4)
Change in coagulation
8 weeks
Change in arterial stiffness (pulse wave velocity)
8 weeks
Change in endothelial function (Flow-mediated dilation)
8 weeks
Effects of sex, race, bone age, and pubertal stage on changes in glucosemetabolism (insulin sensitivity and beta-cell function)
8 weeks
Study Arms (3)
Placebo-Control
PLACEBO COMPARATORThe placebo-control group will take one placebo softgel capsules every day for 8 weeks.
Low-Dose Vitamin K2 (45 mcg/d)
ACTIVE COMPARATORThe low-dose vitamin K2 group will take one 45-mcg vitamin K2 softgel capsule and one placebo softgel capsule every day for 8 weeks.
High-Dose Vitamin K2 (90 mcg/d)
ACTIVE COMPARATORThe high-dose vitamin K2 group will take one 90-mcg vitamin K2 softgel capsules every day for 8 weeks.
Interventions
one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks
one 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Augusta Universitylead
- University of Alabama at Birminghamcollaborator
- Yale Universitycollaborator
- Tufts Universitycollaborator
Study Sites (1)
Medical College of Georgia; Augusta University
Augusta, Georgia, 30909, United States
Related Publications (6)
Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20.
PMID: 21508147BACKGROUNDGower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and beta-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24.
PMID: 23616149BACKGROUNDBooth SL, Centi A, Smith SR, Gundberg C. The role of osteocalcin in human glucose metabolism: marker or mediator? Nat Rev Endocrinol. 2013 Jan;9(1):43-55. doi: 10.1038/nrendo.2012.201. Epub 2012 Nov 13.
PMID: 23147574BACKGROUNDPollock NK. Childhood obesity, bone development, and cardiometabolic risk factors. Mol Cell Endocrinol. 2015 Jul 15;410:52-63. doi: 10.1016/j.mce.2015.03.016. Epub 2015 Mar 27.
PMID: 25817542BACKGROUNDDouthit MK, Fain ME, Nguyen JT, Williams CF, Jasti AH, Gutin B, Pollock NK. Phylloquinone Intake Is Associated with Cardiac Structure and Function in Adolescents. J Nutr. 2017 Oct 1;147(10):1960-1967. doi: 10.3945/jn.117.253666.
PMID: 28794209BACKGROUNDFain ME, Kapuku GK, Paulson WD, Williams CF, Raed A, Dong Y, Knapen MHJ, Vermeer C, Pollock NK. Inactive Matrix Gla Protein, Arterial Stiffness, and Endothelial Function in African American Hemodialysis Patients. Am J Hypertens. 2018 May 7;31(6):735-741. doi: 10.1093/ajh/hpy049.
PMID: 29635270BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman K Pollock, Ph.D.
Department of Medicine, Medical College of Georgia, Augusta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Medicine
Study Record Dates
First Submitted
October 24, 2013
First Posted
October 30, 2013
Study Start
September 1, 2013
Primary Completion
August 30, 2020
Study Completion
December 30, 2020
Last Updated
November 19, 2019
Record last verified: 2019-11