Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
Information source: RWTH Aachen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aortic Valve Calcification
Intervention: Vitamin K supplementation (Dietary Supplement)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: RWTH Aachen University Official(s) and/or principal investigator(s): Ralf Koos, MD, Principal Investigator, Affiliation: RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
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
Clinical Details
Official title: Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
Secondary outcome: progression of diastolic and systolic dysfunction in the three treatment groups
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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- aortic valve calcification,verified by echocardiography
Exclusion Criteria:
- 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
Locations and Contacts
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Aachen, NRW 52074, Germany
Additional Information
Starting date: January 2010
Last updated: November 4, 2014
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