Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
NCT ID: NCT01972113
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2013-09-30
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo-Control
The placebo-control group will take one placebo softgel capsules every day for 8 weeks.
Placebo-Control
one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
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.
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 (90 mcg/d)
The high-dose vitamin K2 group will take one 90-mcg vitamin K2 softgel capsules every day 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
8 Years
17 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Yale University
OTHER
Tufts University
OTHER
Augusta University
OTHER
Responsible Party
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Norman Pollock
Associate Professor, Department of Medicine
Principal Investigators
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Norman K Pollock, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Medical College of Georgia, Augusta University
Locations
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Medical College of Georgia; Augusta University
Augusta, Georgia, United States
Countries
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Central Contacts
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References
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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.
Gower 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.
Booth 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.
Pollock 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.
Douthit 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.
Fain 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.
Other Identifiers
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16GRNT31090037
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
611523 (Pro00000912)
Identifier Type: -
Identifier Source: org_study_id
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