Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
NCT ID: NCT00785109
Last Updated: 2017-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
99 participants
INTERVENTIONAL
2010-01-31
2015-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
100 patients daily additional intake of 2mg vitamin k1
Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
2
100 patients no additional intake of vitamin K
Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
Interventions
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Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Ralf Koos, MD
Role: PRINCIPAL_INVESTIGATOR
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
Locations
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Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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2008-005306-39
Identifier Type: -
Identifier Source: secondary_id
Vitamin K Study
Identifier Type: -
Identifier Source: org_study_id
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