NCT01972113

Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)

Vitamin K and Glucose Metabolism in Children at Risk for Diabetes

• 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

The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.

Conditions

• Obesity
• Insulin Resistance
• Insulin Sensitivity
• Prediabetes
• Dyslipidemia
• Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo-Control	one 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)	one 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks

Timeline

• Start date: 2013-09-01
• Primary completion: 2020-08-30
• Completion: 2020-12-30
• First posted: 2013-10-30
• Last updated: 2019-11-19

Locations

1 site across 1 country: United States