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SLOW-Slower Progress of caLcificatiOn With Vitamin K2

NCT04429035 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-01

No results posted yet for this study

Summary

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

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Calcification
  • Mitral Annular Calcification
  • Mitral Valve Calcification
  • Mitral Valve Stenosis

Interventions

DIETARY_SUPPLEMENT

Vitamin K2

Administration of 300 μg Vitamin K2 (MQ7) daily p.o

DIETARY_SUPPLEMENT

Placebo

Administration of 300 μg Vitamin K2 (MQ7) Placebo daily p.o

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2022-10-23
Completion
2023-12-23

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04429035 on ClinicalTrials.gov