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

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:

  1. Bicuspid aortic valve
  2. Dialysis or CKD
  3. 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

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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