Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
08-002
Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
2 other identifiers
interventional
99
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedApril 21, 2017
April 1, 2017
5.6 years
November 4, 2008
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
18 months
Secondary Outcomes (1)
progression of diastolic and systolic dysfunction in the three treatment groups
18 months
Study Arms (2)
1
EXPERIMENTAL100 patients daily additional intake of 2mg vitamin k1
2
PLACEBO COMPARATOR100 patients no additional intake of vitamin K
Interventions
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
Eligibility Criteria
You may qualify if:
- aortic valve calcification,verified by echocardiography
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, 52074, Germany
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Ralf Koos, MD
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
January 1, 2010
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
April 21, 2017
Record last verified: 2017-04