Back to resultsVitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
Primary Purpose
Obesity, Insulin Resistance, Obesity in Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo-Control
Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)
High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring 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], D11.786.875.844 [Vitamin K 2], D02.806.550.750 [Vitamin K 2], E02.293 [Diet Therapy], E02 [Therapeutics], F04.096.544.215.508.428 [Primary Prevention], N01.224.425.525 [Nutritional Status]
Eligibility 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
Sites / Locations
- Medical College of Georgia; Augusta University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo-Control
Low-Dose Vitamin K2 (45-mcg/d)
High-Dose Vitamin K2 (90-mcg/d)
Arm Description
The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
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.
The high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks.
Outcomes
Primary Outcome Measures
Change in serum lipid concentrations
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
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
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
Change in coagulation
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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02959762
Brief Title
Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
Official Title
Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Obesity in Diabetes, Nutritional and Metabolic Diseases, Hyperlipidemia, Hyperglycemia, Cardiovascular Diseases
Keywords
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], D11.786.875.844 [Vitamin K 2], D02.806.550.750 [Vitamin K 2], E02.293 [Diet Therapy], E02 [Therapeutics], F04.096.544.215.508.428 [Primary Prevention], N01.224.425.525 [Nutritional Status]
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo-Control
Arm Type
Placebo Comparator
Arm Description
The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
Arm Title
Low-Dose Vitamin K2 (45-mcg/d)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-Dose Vitamin K2 (90-mcg/d)
Arm Type
Active Comparator
Arm Description
The high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo-Control
Intervention Description
two placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)
Other Intervention Name(s)
menaquinone-7
Intervention Description
one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
Other Intervention Name(s)
menaquinone-7
Intervention Description
two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
Primary Outcome Measure Information:
Title
Change in serum lipid concentrations
Description
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.
Time Frame
8 weeks
Title
Change in insulin sensitivity
Description
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.
Time Frame
8 weeks
Title
Change in beta-cell function
Description
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.
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Change in coagulation
Description
Coagulation-related parameters (i.e., prothrombin time and activated partial thromboplastin time) will be assessed at baseline and 8 weeks to assess clotting function.
Time Frame
8 weeks
Title
Change in arterial stiffness (pulse wave velocity)
Description
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.
Time Frame
8 weeks
Title
Change in endothelial function (flow-mediated dilation)
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman K Pollock, PhD
Organizational Affiliation
Department of Pediatrics, Medical College of Georgia, Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Georgia; Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Approximate date of when the data will be shared? 2019-06-28
Where will the data be made available? The de-identified data will be made available for research purposes only by contacting the principal investigator.
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.
Citations:
PubMed Identifier
28794209
Citation
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.
Results Reference
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Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
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