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Trial record 37 of 50 for:    vitamin k2

The Aortic Valve DECalcification (AVADEC) Trial (AVADEC)

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ClinicalTrials.gov Identifier: NCT03243890
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Axel Diederichsen, Odense University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Multidetector Computed Tomography Vitamin K 2 Randomised Clinical Trial Dietary Supplement: Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day). Dietary Supplement: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized 1:1 after stratification for site, AVC score (300-599 or ≥600) and statin-use. Each site will be provided with sequentially numbered, opaque and sealed envelopes containing randomly generated treatment allocations. Four different types of envelopes are provided; 1) AVC 300-599, no statin-use; 2) AVC 300-599, statin-use; 3) AVC ≥600, no statin-use; and 4) AVC ≥600, statin-use.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The randomization-list is available to the data and safety monitoring board, but patients, nurses, physicians and other data collectors are kept blinded to the allocation during the study.
Primary Purpose: Prevention
Official Title: The Effects of Menaquinone-7 Supplementation in Patients With Aortic Valves Calcification
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin K

Arm Intervention/treatment
Experimental: Intervention
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).
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).

Placebo Comparator: Placebo
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 placebo treatment (no active treatment).




Primary Outcome Measures :
  1. Aortic valve calcification [ Time Frame: From baseline to two years of follow-up ]
    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).


Secondary Outcome Measures :
  1. Arterial calcification [ Time Frame: From baseline to two years of follow-up ]
    Change in compiled arterial calcification by non-contrast CT

  2. Coronary and carotid plaque composition [ Time Frame: From baseline to two years of follow-up ]
    Change in total plaque burden in the coronaries and carotid arteries by contrast CT

  3. Aortic valve area [ Time Frame: From baseline to two years of follow-up ]
    Change in aortic valve area by transthoracic echocardiography

  4. Bone mineral density [ Time Frame: From baseline to two years of follow-up ]
    Change in bone mineral density as quantitative CT of the columna lumbalis and hip region

  5. Biomarkers of calcification [ Time Frame: From baseline to two years of follow-up ]
    Change in matrix-Gla proteins and osteocalcin with different phosphorylation (p and dp) and carboxylation forms (c and uc).

  6. Quality of life [ Time Frame: From baseline to two years of follow-up ]
    Change in quality of life



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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  • 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
  • A life-expectancy < 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243890


Locations
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Denmark
Department of Cardiology, Odense University Hospital
Odense, Odense C, Denmark, DK-5000
Sponsors and Collaborators
Axel Diederichsen
Investigators
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Principal Investigator: Axel CP Diederichsen, PhD Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Axel Diederichsen, Associated professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03243890     History of Changes
Other Study ID Numbers: AVADEC
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Vitamin K 2
Vitamin K
Vitamin MK 7
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants