Food supplementation with Vitamin K for MGP-activation and inhibition of progression of aortic valve calcificatio

Phase 1

• Conditions: progression of aortic valve calcification; MedDRA version: 20.0Level: PTClassification code 10050559Term: Aortic valve calcificationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2008-005306-39-DE
• Lead Sponsor: RWTH Aachen University, represented by the rector, himself represented by Clinical Trial Center Aachen (CTC-A)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-19
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

patients with echocardiographic determined aortic valve calcification >= 50 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

chronic or acute intestinal diseases
terminal renal failure
known soy allergy
actual Vitamin K supplementation
oral intake of vitamin K antagonists (e.g. Marcumar)
systemic cortisone therapy
present medical history of thrombosis
pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: comparison of progression of coronary and valvular calcification scores under Vitamin K supplementation as compared to a control group without supplementation;Secondary Objective: decrease of level of carboxylation under vitamin K supplementation of the following:<br>ratio ucMGP/cMGP after 1 week, 1, 3, 6, 9 and 12 months<br>decrease of level of carboxylation under vitamin K supplementation for<br>the ratio ucMGP/cMGP after 1 week, 1, 3, 6, 9 and 12 months as compared to the non-supplemented control group<br>comparison of progression of diastolic and systolic dysfunction of the treatment group as compared to the control group using echocardiography and speckle tracking based MRI;Primary end point(s): comparison of increase of calcification scores of treatment groups and control group<br>decrease of ucMGP/cMGP ratio under vitamin K supplementation within each treatment and control group;Timepoint(s) of evaluation of this end point: Last visit last subject (LVLS)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none