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

RWTH Aachen University

Status and phase: Completed; Phase 3

Conditions: Aortic Valve Calcification

Treatments: Dietary Supplement: Vitamin K supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT00785109

Vitamin K Study

2008-005306-39

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

100 patients daily additional intake of 2mg vitamin k1

Treatment:

Dietary Supplement: Vitamin K supplementation

2

Placebo Comparator group

Description:

100 patients no additional intake of vitamin K

Treatment:

Dietary Supplement: Vitamin K supplementation