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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02959762
Other study ID # 931430
Secondary ID 16GRNT31090037
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date December 30, 2020

Study information

Verified date November 2019
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 30, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
Placebo-Control
two placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
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
High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks

Locations

Country Name City State
United States Medical College of Georgia; Augusta University Augusta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

References & 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 Aug 9. pii: jn253666. doi: 10.3945/jn.117.253666. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. 8 weeks
Secondary 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. 8 weeks
Secondary 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. 8 weeks
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