Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
NCT ID: NCT03305536
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2018-01-02
2020-12-31
Brief Summary
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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.
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Detailed Description
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1. 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3
2. 5000 IU/d Vitamin D3 as a control group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Interventional
1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve
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
interventional
5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Focus on patients with:
1. Bicuspid aortic valve
2. Dialysis or CKD
3. Statin treatment
Exclusion Criteria
* Malabsorption Problem
* LVEF \< 40%
* A life expectancy \< 3 years
30 Years
85 Years
ALL
No
Sponsors
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Omicron Pharmaceuticals
INDUSTRY
Nattopharma ASA
INDUSTRY
Hopital St. Georges, Ajaltoun
OTHER
Responsible Party
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Rodolph Frangi
Head of Department of Thoracic and Cardiovascular surgery
Locations
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Hopital Saint-George Ajaltoun
Beirut, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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Rodolphe Frangi, MD
Role: primary
Other Identifiers
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NC27082017
Identifier Type: -
Identifier Source: org_study_id
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