NCT00785109

Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification

Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. This will be done by means of measurements of concentrations from osteocalcine and MPG in blood serum, echocardiography, cardiac computed tomography and cardiac MRI

Detailed description

Patients will be allocated to two groups with either 1. additional intake of 2 mg vitamin k1 daily 2. controll group without additional intake of Vitamin K Treatment group a will include 100 patients, the controll group should include 100 patients. None of all patients should require renal dialysis.

Conditions

• Aortic Valve Calcification

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin K supplementation	Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2008-11-05
• Last updated: 2017-04-21

Locations

1 site across 1 country: Germany