Brief Title
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
Official Title
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.
Brief 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
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
Primary Outcome
Evaluation of calcification change of Aortic valve.Correlation With Mitral annulus and ascending Aorta calcification.A randomized 12-month trial.
Condition
Aortic Valve Stenosis
Intervention
Vitamin K2
Study Arms / Comparison Groups
Vitamin K2
Description: Participants receive Vitamin K2 (Menaquinone) 100mcg tablet orally 3 times daily for 12 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
200
Start Date
September 23, 2019
Completion Date
December 2022
Primary Completion Date
October 2021
Eligibility Criteria
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
Gender
All
Ages
50 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, 00306948694644, [email protected]
Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT04429035
Organization ID
55461
Responsible Party
Principal Investigator
Study Sponsor
National and Kapodistrian University of Athens
Study Sponsor
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Verification Date
June 2020