Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
|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.|
|ClinicalTrials.gov Identifier: NCT01972113|
Recruitment Status : Recruiting
First Posted : October 30, 2013
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance Insulin Sensitivity Prediabetes Dyslipidemia Diabetes||Dietary Supplement: Placebo-Control Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d) Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vitamin K and Glucose Metabolism in Children at Risk for Diabetes|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Placebo Comparator: Placebo-Control
The placebo-control group will take one placebo softgel capsules every day for 8 weeks.
Dietary Supplement: Placebo-Control
one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
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.
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
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.
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
- Change in serum lipid concentrations [ Time Frame: 8 weeks ]To determine if vitamin K supplementation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner.
- Change in insulin sensitivity [ Time Frame: 8 weeks ]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.
- Change in beta-cell function [ Time Frame: 8 weeks ]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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972113
|Contact: Norman K Pollock, Ph.D.||firstname.lastname@example.org|
|Contact: Celestine F Williams, M.S.||email@example.com|
|United States, Georgia|
|Medical College of Georgia; Augusta University||Recruiting|
|Augusta, Georgia, United States, 30909|
|Principal Investigator: Norman K Pollock, Ph.D.|
|Principal Investigator:||Norman K Pollock, Ph.D.||Department of Pediatrics, Medical College of Georgia, Augusta University|