Status:
COMPLETED
Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
Lead Sponsor:
RWTH Aachen University
Conditions:
Aortic Valve Calcification
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 ...
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 patient...
Eligibility Criteria
Inclusion
- aortic valve calcification,verified by echocardiography
Exclusion
- chronic or acute intestinal diseases
- terminal renal failure
- allergic reaction on soya containing products
- recent additional intake of vitamin K
- oral anticoagulation with vitamin K antagonists (Marcoumar)
- systemic therapy with corticosteroids
- anamnestic venous thrombosis (pelvet or legs)or embolization of lung arteria
- pregnant or breastfeeding women
- persons without mental ability or capacity to understand and follow the instructions of the investigator
- women of childbearing age without safe contraceptional devices
- minority
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00785109
Start Date
January 1 2010
End Date
August 1 2015
Last Update
April 21 2017
Active Locations (1)
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1
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, Germany, 52074