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Study protocol of t...
Study protocol of the InterVitaminK trial : A Danish population-based randomised double-blinded placebo-controlled trial of the effects of vitamin K (menaquinone-7) supplementation on cardiovascular, metabolic and bone health
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- Kampmann, Freja Bach (författare)
- Frederiksberg Hospital
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- Thysen, Sanne Marie (författare)
- Frederiksberg Hospital
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- Nielsen, Camilla Friis Bryde (författare)
- Frederiksberg Hospital
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- Kofoed, Klaus Fuglsang (författare)
- Copenhagen University Hospital,University of Copenhagen
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- Køber, Lars (författare)
- Copenhagen University Hospital
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- Pham, Michael Huy Cuong (författare)
- Copenhagen University Hospital
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- Vaag, Allan (författare)
- Lund University,Lunds universitet,Translationell diabetesforskning,Forskargrupper vid Lunds universitet,Translational Diabetes Research,Lund University Research Groups,Copenhagen University Hospital,Skåne University Hospital
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- Jørgensen, Niklas Rye (författare)
- Copenhagen University Hospital,University of Copenhagen
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- Petersen, Janne (författare)
- University of Copenhagen,Frederiksberg Hospital
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- Jacobsen, Rikke Kart (författare)
- Frederiksberg Hospital
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- Kårhus, Line Lund (författare)
- Frederiksberg Hospital
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- Diederichsen, Axel (författare)
- Odense University Hospital
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- Frimodt-Møller, Marie (författare)
- Copenhagen University Hospital
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- Linneberg, Allan (författare)
- University of Copenhagen,Frederiksberg Hospital
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(creator_code:org_t)
- 2023
- 2023
- Engelska.
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Ingår i: BMJ Open. - 2044-6055. ; 13:5
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Introduction Vitamin K has been suggested to have protective effects against progression of vascular calcification and development of cardiovascular disease (CVD). However, few well-powered randomised controlled trials have examined whether vitamin K prevents progression of vascular calcification in individuals from the general population. The aim of the InterVitaminK trial is to investigate the effects of vitamin K supplementation (menaquinone-7, MK-7) on cardiovascular, metabolic, respiratory and bone health in a general ageing population with detectable vascular calcification. Methods and analysis The InterVitaminK trial is a randomised, double-blinded, placebo-controlled, trial. A total of 450 men and women aged 52-82 years with detectable coronary artery calcification (CAC), but without manifest CVD, will be randomised (1:1) to receive daily MK-7 (333 μg/day) or placebo tablets for 3 years. Health examinations are scheduled at baseline, and after 1, 2 and 3 years of intervention. Health examinations include cardiac CT scans, measurements of arterial stiffness, blood pressure, lung function, physical function, muscle strength, anthropometric measures, questionnaires on general health and dietary intake, and blood and urine sampling. The primary outcome is progression of CAC from baseline to 3-year follow-up. The trial has 89% power to detect a between-group difference of at least 15%. Secondary outcomes are bone mineral density, pulmonary function and biomarkers of insulin resistance. Ethics and dissemination Oral MK-7 supplementation is considered safe and has not been found to cause severe adverse events. The Ethical Committee of the Capital Region (H-21033114) approved the protocol. Written informed consent is obtained from all participants and the trial is conducted in accordance with the Declaration of Helsinki II. Both negative and positive findings will be reported. Trial registration number NCT05259046.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- Calcium & bone
- CARDIOLOGY
- General endocrinology
- NUTRITION & DIETETICS
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Vaag, Allan
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