SLOW-Slower Progress of caLcificatiOn With Vitamin K2

August 31, 2021 updated by: Konstantinos Toutouzas, National and Kapodistrian University of Athens

Inhibition of Aortic Valve Calcification Through the Carboxylation Mechanism of Matrix Gla Protein (MGP), Following Administration of Vitamin K2 (Menaquinone-7). Correlation With Mitral Annulus and Ascending Aorta Calcification.

A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo on a daily basis as well. Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression. Correlation with Mitral annulus and ascending Aorta.Exclusion criteria: Chronic Kidney disease, Vitamin K antagonists, statins, age < 50 y.o,prosthetic valves,Aortic Valve area (AVA) < 1cm2 ,Vmax > 4 m/s

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For the purposes of this study, all individuals will be subjected to the same quantitative and qualitative tests, before and after the daily administration of 300mcg K2 vitamin/placebo for a period of one year.Clinical examination,extensive blood laboratory tests,direct measurement of Dephosphorylated-uncarboxylated MGP(dp-ucMGP), Echocardiogram and ECS,carotid ultrasound,ophthalmologic exam,further imaging methods with MSCT Calcium Score(Agatston score) will take place.Correlations with their medical and pharmacological therapy history.

Before and after the administration of VK2/placebo, the following measurements will take place i)Quantitative and percentile rate determination of Aortic Valve, Mitral Valve and Ascending Aorta calcification via MSCT Calcium score without contrast.

ii)Echocardiogram and calcification evaluation via Echocardiographic Calcium Score (ECS), iii)Determination of changes in carotid intima-media thickness (cIMT) and Carotid stenosis iv)Standard ophthalmologic examination v)Direct measurement of Dephosphorylated-uncarboxylated MGP(dp-ucMGP) vi)Correlation with blood biomarkers

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Symeon Evangelos Mavroudeas, MD
  • Phone Number: 00306948694644
  • Email: akis-m@hotmail.com

Study Contact Backup

  • Name: Konstantinos P Toutouzas, Professor

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • First Department of Cardiology, University of Athens
        • Contact:
        • Contact:
          • Konstantinos P Toutouzas, Professor
          • Phone Number: 00302132088147
          • Email: ktoutouz@gmail.com
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • Hippokration Hospital 1st Department of Cardiology,National and Kapodistrian University of Athens,Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASYMPTOMATIC AV STENOSIS WITH AVA>1 cm2 & Vmax<4m/s

Exclusion Criteria:

  • AVK,STATINS,MSCT THE LAST 6 MONTHS,PROSTHETIC VALVES, AVA<1 cm2,Vmax>4m/s

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin K2
Participants receive Vitamin K2 (Menaquinone) 100mcg tablet orally 3 times daily for 12 months.
Dietary supplement: Vitamin K2
Administration of 300 μg Vitamin K2 (MQ7) daily p.o
Placebo Comparator: Placebo
Participants receive Vitamin K2 (Menaquinone) placebo tablet matching Vitamin K2 (Menaquinone) orally 3 times daily for 12 months.
Dietary supplement: Placebo
Administration of 300 μg Vitamin K2 (MQ7) Placebo daily p.o

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of calcification change of Aortic valve.Correlation With Mitral annulus and ascending Aorta calcification.A randomized 12-month trial.
Time Frame: Each patient will be evaluated twice a year.Once before the administartion of VK2/Placebo and after a period of a 12 month administration of VK2/PLACEBO
The calcification change will be evaluated via a 64 MSCT scanner measuring the calcium via Agatston score, before and after administration of VK2/placebo.The following measurements will take place and after 12 months will be compared.
Each patient will be evaluated twice a year.Once before the administartion of VK2/Placebo and after a period of a 12 month administration of VK2/PLACEBO

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2019

Primary Completion (Anticipated)

October 23, 2022

Study Completion (Anticipated)

December 23, 2023

Study Registration Dates

First Submitted

May 31, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55461

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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