Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
Phase 3
Completed
- Conditions
- Aortic Valve Calcification
- Interventions
- Dietary Supplement: Vitamin K supplementation
- Registration Number
- NCT00785109
- Lead Sponsor
- RWTH Aachen University
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Vitamin K supplementation 100 patients daily additional intake of 2mg vitamin k1 2 Vitamin K supplementation 100 patients no additional intake of vitamin K
- Primary Outcome Measures
Name Time Method Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K 18 months
- Secondary Outcome Measures
Name Time Method progression of diastolic and systolic dysfunction in the three treatment groups 18 months
Trial Locations
- Locations (1)
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
🇩🇪Aachen, NRW, Germany