Trials / Unknown

UnknownNCT02959762

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

Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 30 (estimated)

Sponsor: Augusta University · Academic / Other
Sex: All
Age: 8 Years – 17 Years
Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

Start date: 2016-10-01
Primary completion: 2020-12-01
Completion: 2020-12-30
First posted: 2016-11-09
Last updated: 2019-11-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02959762. Inclusion in this directory is not an endorsement.