search
Back to results

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

Primary Purpose

Aortic Valve Calcification

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Vitamin K supplementation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Calcification focused on measuring aortic valve calcification, vitamin K supplementation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

100 patients daily additional intake of 2mg vitamin k1

100 patients no additional intake of vitamin K

Outcomes

Primary Outcome Measures

Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K

Secondary Outcome Measures

progression of diastolic and systolic dysfunction in the three treatment groups

Full Information

First Posted
November 4, 2008
Last Updated
April 20, 2017
Sponsor
RWTH Aachen University
search

1. Study Identification

Unique Protocol Identification Number
NCT00785109
Brief Title
Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
Acronym
08-002
Official Title
Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Calcification
Keywords
aortic valve calcification, vitamin K supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
100 patients daily additional intake of 2mg vitamin k1
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
100 patients no additional intake of vitamin K
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K supplementation
Intervention Description
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
progression of diastolic and systolic dysfunction in the three treatment groups
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Koos, MD
Organizational Affiliation
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification

We'll reach out to this number within 24 hrs