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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00785109
First received: November 4, 2008
Last updated: September 22, 2015
Last verified: September 2015
  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:


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 ]

Enrollment: 117
Study Start Date: January 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785109

Locations
Germany
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Ralf Koos, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
  More Information

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: September 22, 2015
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
Aortic Valve Stenosis
Calcium Metabolism Disorders
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Vitamins
Vitamin K
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on September 23, 2016