- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02959762
Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
November 18, 2019 updated by: Norman Pollock, Augusta University
Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk
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).
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
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Augusta, Georgia, United States, 30912
- Medical College of Georgia; Augusta University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo-Control
The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
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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.
|
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 Names:
|
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.
|
two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
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.
|
8 weeks
|
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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8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Norman K Pollock, PhD, Department of Pediatrics, Medical College of Georgia, Augusta University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
November 7, 2016
First Posted (Estimate)
November 9, 2016
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 18, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
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]
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Endocrine System Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Hyperinsulinism
- Lipid Metabolism Disorders
- Hyperglycemia
- Cardiovascular Diseases
- Diabetes Mellitus
- Obesity
- Dyslipidemias
- Insulin Resistance
- Hyperlipidemias
- Metabolic Diseases
- Hyperlipoproteinemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Micronutrients
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin K
- Vitamins
- Vitamin K 2
- Vitamin MK 7
Other Study ID Numbers
- 931430
- 16GRNT31090037 (Other Grant/Funding Number: American Heart Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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