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

Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00785109

Acronym

08-002

Enrollment

Registered

2008-11-05

Start date

2010-01-31

Completion date

2015-08-31

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Calcification

Keywords

aortic valve calcification, vitamin K supplementation

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 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.

Interventions

DIETARY_SUPPLEMENTVitamin K supplementation

Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K	18 months

Secondary

Measure	Time frame
progression of diastolic and systolic dysfunction in the three treatment groups	18 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026