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

H

Hopital St. Georges, Ajaltoun

Status and phase

Unknown
Phase 2

Conditions

Aortic Valve Disease

Treatments

Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03305536
NC27082017

Details and patient eligibility

About

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.

Full description

The study is a randomized clinical trial that will use Cardiac Echography and multi-detector computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS) over 3 years when using: 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3 5000 IU/d Vitamin D3 as a control group

Enrollment

150 estimated patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

AVCS > 300 without aortic valve stenosis requiring operation

Focus on patients with:

  • Bicuspid aortic valve
  • Dialysis or CKD
  • Statin treatment

Exclusion criteria

  • Use of Vitamin K antagonist
  • Malabsorption Problem
  • LVEF < 40%
  • A life expectancy < 3 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups

Interventional
Active Comparator group
Description:
1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve
Treatment:
Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3
interventional
Active Comparator group
Description:
5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
Treatment:
Dietary Supplement: Vitamin K2 (Menaquinone 7) + Vitamin D3

Trial contacts and locations

0

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Central trial contact

Rodoplh Frangi, MD

Data sourced from clinicaltrials.gov

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