Vitamin K Supplement for Inhibition of the Progress in Ao... | NCT00785109

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

NCT00785109

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Apr 21, 2017Actual

Enrollment

99Actual

Phase

Phase 3

Conditions

Aortic Valve Calcification

Interventions

Vitamin K supplementation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-005306-39

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2017

Last Update Posted Date

Apr 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	100 patients daily additional intake of 2mg vitamin k1	Dietary Supplement: Vitamin K supplementation
2	Placebo Comparator	100 patients no additional intake of vitamin K	Dietary Supplement: Vitamin K supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin K supplementation	Dietary Supplement	Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2	1 2

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ralf Koos, MD	RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine		Aachen	North Rhine-Westphalia	52074	Germany

Condition Browse Module

MeSH Terms

ID	Term
C562942	Aortic Valve, Calcification of

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided