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

NCT02959762 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-11-20

No results posted yet for this study

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo-Control

two placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)

two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Norman K Pollock, PhD · Department of Pediatrics, Medical College of Georgia, Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-12-01
Completion
2020-12-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02959762 on ClinicalTrials.gov