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
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...
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| Format: | Article |
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BMJ Publishing Group
2023-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e071885.full |
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| author | Allan Linneberg Lars Køber Allan Vaag Sanne Marie Thysen Freja Bach Kampmann Rikke Kart Jacobsen Axel Diederichsen Janne Petersen Niklas Rye Jørgensen Klaus Fuglsang Kofoed Marie Frimodt-Moller Line Lund Kårhus Camilla Friis Bryde Nielsen Michael Huy Cuong Pham |
| author_facet | Allan Linneberg Lars Køber Allan Vaag Sanne Marie Thysen Freja Bach Kampmann Rikke Kart Jacobsen Axel Diederichsen Janne Petersen Niklas Rye Jørgensen Klaus Fuglsang Kofoed Marie Frimodt-Moller Line Lund Kårhus Camilla Friis Bryde Nielsen Michael Huy Cuong Pham |
| author_sort | Allan Linneberg |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-13T10:22:59Z |
| format | Article |
| id | doaj.art-8fe4eae2c0c241249790a997494b0a25 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-13T10:22:59Z |
| publishDate | 2023-05-01 |
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| series | BMJ Open |
| spelling | doaj.art-8fe4eae2c0c241249790a997494b0a252023-05-20T02:30:07ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2023-071885Study 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 healthAllan Linneberg0Lars Køber1Allan Vaag2Sanne Marie Thysen3Freja Bach Kampmann4Rikke Kart Jacobsen5Axel Diederichsen6Janne Petersen7Niklas Rye Jørgensen8Klaus Fuglsang Kofoed9Marie Frimodt-Moller10Line Lund Kårhus11Camilla Friis Bryde Nielsen12Michael Huy Cuong Pham1313 Department of Clinical Experimental Research, Rigshospitalet, Copenhagen, DenmarkDepartment of Cardiology, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark4 Cardiovascular and Metabolic Disease (CVMD)Translational Medicine Unit, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Mölndal, SwedenCenter for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, DenmarkDepartment of Endocrinology, Rigshospitalet, Copenhagen, Denmark2 Center for Clinical Research and Prevention, Frederiksberg Hospital, Frederiksberg, DenmarkDepartment of Cardiology, Odense University Hospital, Odense, Denmark1 Clinical Research Centre, Copenhagen University Hospital Hvidovre, Hvidovre, DenmarkDepartment of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital, Copenhagen, DenmarkComplications Research, Steno Diabetes Center Copenhagen, Copenhagen, DenmarkCentre for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, DenmarkCenter for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, DenmarkDepartment of Cardiology and Radiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, DenmarkIntroduction 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.https://bmjopen.bmj.com/content/13/5/e071885.full |
| spellingShingle | Allan Linneberg Lars Køber Allan Vaag Sanne Marie Thysen Freja Bach Kampmann Rikke Kart Jacobsen Axel Diederichsen Janne Petersen Niklas Rye Jørgensen Klaus Fuglsang Kofoed Marie Frimodt-Moller Line Lund Kårhus Camilla Friis Bryde Nielsen Michael Huy Cuong Pham 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/5/e071885.full |
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