Clinical Trial: Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
Brief 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 Summary:
Patients will be allocated to two groups with either
- additional intake of 2 mg vitamin k1 daily
- 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.
Sponsor: RWTH Aachen University
Current Primary Outcome: Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: progression of diastolic and systolic dysfunction in the three treatment groups [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: RWTH Aachen University
Dates:
Date Received: November 4, 2008
Date Started: January 2010
Date Completion:
Last Updated: April 20, 2017
Last Verified: April 2017
