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Trial record 16 of 50 for:    vitamin k2

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
Sponsor:
Information provided by (Responsible Party):
Norman Pollock, Augusta University

Brief Summary:
Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 8 to 17 years
  • Body mass index equal to or greater than 85th percentile for age and sex
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Norman K Pollock, PhD 706-721-5424 npollock@augusta.edu
Contact: Celestine Williams, MS 706-721-8553 cewilliams@augusta.edu

Locations
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United States, Georgia
Medical College of Georgia; Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Norman K Pollock, Ph.D.    706-721-5424    npollock@augusta.edu   
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Norman K Pollock, PhD Department of Pediatrics, Medical College of Georgia, Augusta University

Publications:
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Responsible Party: Norman Pollock, Associate Professor, Augusta University
ClinicalTrials.gov Identifier: NCT02959762     History of Changes
Other Study ID Numbers: 931430
16GRNT31090037 ( Other Grant/Funding Number: American Heart Association )
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  1. Approximate date of when the data will be shared? 2019-06-28
  2. Where will the data be made available? The de-identified data will be made available for research purposes only by contacting the principal investigator.
  3. Please explain any limits to data sharing that might be required. Even though the final research data will be stripped of identifiers prior to release for sharing, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the investigators will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Keywords provided by Norman Pollock, Augusta University:
D11.786.875.844 [Vitamin K 2]
D02.806.550.750 [Vitamin K 2]
G01 [Biological Sciences]
G02.513 [Nutrition]
G06.696.259 [Child Nutrition]
G07.553.481.398.571 [Obesity]
G06 [Biochemical Phenomena, Metabolism, and Nutrition]
G12.392.617 [Insulin Resistance]
G06.696.259.500 [Adolescent Nutrition]
A06 [Endocrine System]
A07 [Cardiovascular System]
C18.452.297.681 [Obesity in Diabetes]
C18.452.555 [Insulin Resistance]
C18 [Nutritional and Metabolic Diseases]
C18.452.494 [Hyperlipidemia]
C18.452.460 [Hyperglycemia]
C14 [Cardiovascular Diseases]
E02.293 [Diet Therapy]
E02 [Therapeutics]
F04.096.544.215.508.428 [Primary Prevention]
N01.224.425.525 [Nutritional Status]
Additional relevant MeSH terms:
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Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Diabetes Mellitus
Obesity
Insulin Resistance
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Hyperglycemia
Metabolic Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Lipid Metabolism Disorders
Physiological Effects of Drugs
Micronutrients
Nutrients
Growth Substances
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics