- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785109
Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification (08-002)
April 20, 2017 updated by: RWTH Aachen University
Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be allocated to two groups with either
- additional intake of 2 mg vitamin k1 daily
- 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.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
100 patients daily additional intake of 2mg vitamin k1
|
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
|
Placebo Comparator: 2
100 patients no additional intake of vitamin K
|
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression of diastolic and systolic dysfunction in the three treatment groups
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ralf Koos, MD, RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
November 4, 2008
First Submitted That Met QC Criteria
November 4, 2008
First Posted (Estimate)
November 5, 2008
Study Record Updates
Last Update Posted (Actual)
April 21, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Aortic Valve Disease
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Calcium Metabolism Disorders
- Aortic Valve Stenosis
- Calcinosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Micronutrients
- Vitamins
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin K
Other Study ID Numbers
- Vitamin K Study
- 2008-005306-39
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Instituto Nacional de Cardiologia Ignacio ChavezCompletedAortic Valve Stenosis | Aortic Valve Disease | Aortic Valve Calcification | Prosthetic Valve MalfunctionMexico
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Venus MedTech (HangZhou) Inc.UnknownAortic Valve Stenosis | Aortic Valve CalcificationChina
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Modarres HospitalCompleted
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National and Kapodistrian University of AthensUniversity of Oxford; Naval Hospital of Athens; Biomedical Research Foundation...RecruitingAortic Valve Stenosis | Calcific Aortic Valve Disease | Aortic Valve, Calcification ofGreece
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Foldax, IncActive, not recruitingAortic Valve Stenosis | Aortic Valve Disease | Aortic Valve Insufficiency | Aortic Valve CalcificationIndia
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Cardiawave SAQbD ClinicalActive, not recruitingAortic Valve Stenosis | Aortic Valve CalcificationFrance, Netherlands, Germany
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Wuhan Union Hospital, ChinaNot yet recruitingAortic Valve Stenosis | Calcification of Aortic Valve
Clinical Trials on Vitamin K supplementation
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Rogier CaluweCompleted
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University of WashingtonNational Institute of General Medical Sciences (NIGMS)Terminated
-
Ain Shams UniversityCompletedEnd Stage Renal Disease on DialysisEgypt
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DaniscoCompleted
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Maastricht University Medical CenterCompletedCarboxylation Level | Vitamin K-dependent ProteinsNetherlands
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Maastricht University Medical CenterCompleted
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HaEmek Medical Center, IsraelWithdrawn
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Institut de Recherche en Sciences de la Sante,...Active, not recruitingMalaria | Malnutrition, ChildBurkina Faso
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RWTH Aachen UniversityCompleted