Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)

Obesity Clinical Trial

Official title:

Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk

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
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Dyslipidemias
• Hyperglycemia
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Insulin Resistance
• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Obesity
• Obesity in Diabetes

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