Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)
2 other identifiers
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2016
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 11, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedNovember 20, 2019
November 1, 2019
4.2 years
October 11, 2016
November 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
8 weeks
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.
8 weeks
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.
8-weeks
Secondary Outcomes (3)
Change in coagulation
8 weeks
Change in arterial stiffness (pulse wave velocity)
8 weeks
Change in endothelial function (flow-mediated dilation)
8 weeks
Study Arms (3)
Placebo-Control
PLACEBO COMPARATORThe placebo-control group will take two placebo softgel capsules every day for 8 weeks.
Low-Dose Vitamin K2 (45-mcg/d)
ACTIVE COMPARATORThe low-dose vitamin K2 group will take one 45-mcg vitamin K2 softgel capsule and one placebo softgel capsule every day for 8 weeks.
High-Dose Vitamin K2 (90-mcg/d)
ACTIVE COMPARATORThe high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks.
Interventions
two placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks
two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical College of Georgia; Augusta University
Augusta, Georgia, 30912, United States
Related Publications (1)
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.
PMID: 28794209BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman K Pollock, PhD
Department of Pediatrics, Medical College of Georgia, Augusta University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 11, 2016
First Posted
November 9, 2016
Study Start
October 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 30, 2020
Last Updated
November 20, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
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.