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Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification (08-002)

This study is currently recruiting participants.
Verified March 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00785109
First received: November 4, 2008
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Aortic Valve Calcification
 Dietary Supplement: Vitamin K supplementation
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process

Resource links provided by NLM:

Drug Information available for: Menadione
U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression of diastolic and systolic dysfunction in the three treatment groups [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
100 patients daily additional intake of 2mg vitamin k1
 Dietary Supplement: Vitamin K supplementation
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
 Dietary Supplement: Vitamin K supplementation
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785109

Contacts
Contact: Ralf Koos, MD ++49 241 ext 8035624 rkoos@ukaachen.de

Locations
Germany
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine Recruiting
Aachen, NRW, Germany, 52074
Contact: Ralf Koos, MD     ++49 241 ext 8080092     rkoos@ukaachen.de    
Contact: Verena Deserno, M.Sc.     ++49 241 ext 8090092     vdeserno@ukaachen.de    
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Ralf Koos, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00785109     History of Changes
Other Study ID Numbers: Vitamin K Study, 2008-005306-39
Study First Received: November 4, 2008
Last Updated: March 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
aortic valve calcification
vitamin K supplementation

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin K
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013