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The Aortic Valve DECalcification (AVADEC) Trial
Plain-language guide to NCT03243890: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 389 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03243890
- Phase
- not phased
- Status
- completed
- Start
- 2018-01-12
- Completion (planned or actual)
- 2021-05-01
- Participants
- 389 (actual)
- Design
- randomized, quadruple-blind, prevention
- Conditions studied
- Aortic Valve Stenosis; Multidetector Computed Tomography; Vitamin K 2; Randomised Clinical Trial
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.
It had two arms (groups): Intervention (experimental) and Placebo (placebo comparator).
Placebo tablet (no active treatment). The placebo tablet is matched to the study drug for taste, color, and size.
The registry classes the interventions as dietary supplement.
Who Took Part
Enrollment: 389 actual participants took part.
It was open to men only aged from 65 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 4 exclusion criteria; among the exclusions: known aortic valve disease (peak velocity ≥3.0 m/s); history of venous thrombosis or other coagulation disorders or use of vitamin k antagonists; disorders of calcium and phosphate metabolism.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.
The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2018-01-12 with completion listed for 2021-05-01.
It ran at 1 site in Denmark.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): Aortic valve calcification (time frame: From baseline to two years of follow-up).
It also tracked 7 secondary outcomes, for example Arterial calcification, Aortic size, Coronary plaque composition, Aortic valve area, Bone mineral density and Biomarkers of calcification.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 389 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.
Our Notes on the Compound
Vitamin D, K2, Magnesium and Zinc: Magnesium is described as required for AMPK to function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.