NCT03243890

The Aortic Valve DECalcification (AVADEC) Trial

The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: Axel Diederichsen · Academic / Other
• Sex: Male
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Valve Stenosis
• Multidetector Computed Tomography
• Vitamin K 2
• Randomised Clinical Trial

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).	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).
DIETARY_SUPPLEMENT	Placebo	Half of the patients are randomized to placebo treatment (no active treatment).

Timeline

• Start date: 2018-01-12
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2017-08-09
• Last updated: 2022-09-29

Locations

1 site across 1 country: Denmark