A Phase 2 interventional study of Vitamin K2 (Menaquinone 7) + Vitamin D3 in Aortic Valve Disease, sponsored by Hopital St. Georges, Ajaltoun. Status unknown at 1 site in Lebanon. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by Hopital St. Georges, Ajaltoun · Phase 2, Interventional, and Treatment
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.
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:
Focus on patients with:
Exclusion Criteria:
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
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
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
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
Time frame: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
Time frame: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
Time frame: 3 years
Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.
1. Lowering of dephosphorelated-undercarboxylated matrix Gla protein (dp-ucMGP picomol/l) 2. Reduction of the Aortic Valve Calcification Score(AVCS) 3. Improvement of dyspnea according to the New York Heart Association Classification(NYHA) 4. Improvement of the quality of life of the patients( physical activity, mobility)
Time frame: 3 years
Reduction of the Aortic Valve calcification measured by CT Scan
Reduction of the Aortic Valve Calcification Score (AVCS)
Time frame: 3 years
Improvement of dyspnea (at rest and effort)
Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
Time frame: 3 years
Improvement of the quality of life of the patients
Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014
Time frame: 3 years
Plan to share: Undecided
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