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Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)

NCT03305536 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-08-09

No results posted yet for this study

Summary

Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated. Until now surgery remains the only reliable and effective treatment.

In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7) supplementation (1000 mcg)/day on the progression of the aortic valve disease. The investigators hypothesize that MK-7 supplementation may slow or even reverse the progression of the disease process.

Conditions

  • Aortic Valve Disease

Interventions

DIETARY_SUPPLEMENT

Vitamin K2 (Menaquinone 7) + Vitamin D3

Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease

Sponsors & Collaborators

  • Omicron Pharmaceuticals

    collaborator INDUSTRY

  • Nattopharma ASA

    collaborator INDUSTRY

  • Hopital St. Georges, Ajaltoun

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Lebanon

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 NCT03305536 on ClinicalTrials.gov