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

Sponsor

RWTH Aachen University (Other)

Overall Status

Completed

CT.gov ID

NCT00785109

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Calcification	Dietary Supplement: Vitamin K supplementation	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K [18 months]

Secondary Outcome Measures

progression of diastolic and systolic dysfunction in the three treatment groups [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RWTH Aachen University

ClinicalTrials.gov Identifier:

NCT00785109

Other Study ID Numbers:

Vitamin K Study
2008-005306-39

First Posted:

Nov 5, 2008

Last Update Posted:

Apr 21, 2017

Last Verified:

Apr 1, 2017

Keywords provided by RWTH Aachen University

aortic valve calcification

vitamin K supplementation

Additional relevant MeSH terms:

Aortic Valve Stenosis

Calcinosis

Vitamin K

Study Results

No Results Posted as of Apr 21, 2017