An interventional study of Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day). and Placebo in Aortic Valve Stenosis, Multidetector Computed Tomography and Vitamin K 2, sponsored by Axel Diederichsen. Completed at 1 site in Denmark. Open to male participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by Axel Diederichsen · Not applicable, Interventional, and Prevention
Aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps. A few attempts with medical preventive treatment have failed, thus presently the only effective treatment of aortic stenosis is surgery. This study will examine the effect of menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC). The investigators hypothesize that MK-7 supplementation will slow down the calcification process.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 389 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →This is the only study on the registry with Axel Diederichsen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants in the Danish Cardiovascular Screening Trial (Trials. 2015 Dec 5;16:554) with an aortic valve calcification score above 300, but without aortic valve stenosis are eligible.
Exclusion Criteria:
Study drug. Supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day)
Dietary Supplement: Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
Placebo tablet (no active treatment). The placebo tablet is matched to the study drug for taste, color, and size.
Dietary Supplement: Placebo
Half of the patients are randomized to supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day).
Half of the patients are randomized to placebo treatment (no active treatment).
Aortic valve calcification
The primary endpoint is the change in aortic valve calcification. The natural history of the aortic valve calcification is not adequately understood, and accordingly the changes are analyzed in two prespecified patient subgroups (AVC score 300-599 and ≥600, respectively).
Time frame: From baseline to two years of follow-up
Arterial calcification
Change in compiled arterial calcification by non-contrast CT
Time frame: From baseline to two years of follow-up
Aortic size
Change in aortic diameter
Time frame: From baseline to two years of follow-up
Coronary plaque composition
Change in total plaque burden in the coronaries and carotid arteries by contrast CT
Time frame: From baseline to two years of follow-up
Aortic valve area
Change in aortic valve area by transthoracic echocardiography
Time frame: From baseline to two years of follow-up
Bone mineral density
Change in bone mineral density as quantitative CT of the columna lumbalis and hip region
Time frame: From baseline to two years of follow-up
Biomarkers of calcification
Change in matrix-Gla proteins and osteocalcin with different phosphorylation (p and dp) and carboxylation forms (c and uc).
Time frame: From baseline to two years of follow-up
Quality of life
Change in quality of life
Time frame: From baseline to two years of follow-up
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