Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
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|ClinicalTrials.gov Identifier: NCT02959762|
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance Obesity in Diabetes Nutritional and Metabolic Diseases Hyperlipidemia Hyperglycemia Cardiovascular Diseases||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 to Slow Progression of Dyslipidemia and Diabetes Risk|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Placebo Comparator: Placebo-Control
The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
Dietary Supplement: Placebo-Control
two 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 two 45-mcg vitamin K2 softgel capsules every day for 8 weeks.
Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
two 45-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 the vitamin K-induced change in matrix Gla protein carboxylation 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 the vitamin K-induced change in osteocalcin carboxylation 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 ]To determine if the vitamin K-induced change in osteocalcin carboxylation 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 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.
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): NCT02959762
|Contact: Norman K Pollock, PhDfirstname.lastname@example.org|
|Contact: Celestine Williams, MSemail@example.com|
|United States, Georgia|
|Medical College of Georgia; Augusta University||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Norman K Pollock, Ph.D. 706-721-5424 firstname.lastname@example.org|
|Principal Investigator:||Norman K Pollock, PhD||Department of Pediatrics, Medical College of Georgia, Augusta University|