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

NCT03305536 | Unknown Phase 2 DMC

• 1 other identifier: NC27082017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AVD

Outcome Measures

Primary Outcomes (3)

• Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)

  3 years

• Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)

  3 years

• Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)

  3 years

Secondary Outcomes (4)

• Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.

  3 years

• Reduction of the Aortic Valve calcification measured by CT Scan

  3 years

• Improvement of dyspnea (at rest and effort)

  3 years

• Improvement of the quality of life of the patients

  3 years

Study Arms (2)

Interventional

ACTIVE COMPARATOR

1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve

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

interventional

ACTIVE COMPARATOR

5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study

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

Interventions

Vitamin K2 (Menaquinone 7) + Vitamin D3 DIETARY_SUPPLEMENT

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

Also known as: K2/D3

Interventional; interventional

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AVCS \> 300 without aortic valve stenosis requiring operation
• Focus on patients with:
• Bicuspid aortic valve
• Dialysis or CKD
• Statin treatment

You may not qualify if:

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

Sponsors & Collaborators

• Hopital St. Georges, Ajaltoun: lead
• Omicron Pharmaceuticals: collaborator
• Nattopharma ASA: collaborator

Study Sites (1)

Hopital Saint-George Ajaltoun

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Vitamin K 2; menaquinone 7; Cholecalciferol

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Rodoplh Frangi, MD

CONTACT

00961 9 234 202; drfrangi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Thoracic and Cardiovascular surgery

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: October 10, 2017
• Study Start: January 2, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

LE (1)