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
(2023) In BMJ Open 13(5).- Abstract
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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2023
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Calcium & bone, CARDIOLOGY, General endocrinology, NUTRITION & DIETETICS
- in
- BMJ Open
- volume
- 13
- issue
- 5
- article number
- e071885
- publisher
- BMJ Publishing Group
- external identifiers
-
- pmid:37208133
- scopus:85159691396
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2023-071885
- language
- English
- LU publication?
- yes
- id
- 30144d51-36ff-4d29-bb62-bff0b71d9af1
- date added to LUP
- 2023-08-22 12:23:35
- date last changed
- 2024-04-20 01:14:18
@article{30144d51-36ff-4d29-bb62-bff0b71d9af1,
abstract = {{<p>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.</p>}},
author = {{Kampmann, Freja Bach and Thysen, Sanne Marie and Nielsen, Camilla Friis Bryde and Kofoed, Klaus Fuglsang and Køber, Lars and Pham, Michael Huy Cuong and Vaag, Allan and Jørgensen, Niklas Rye and Petersen, Janne and Jacobsen, Rikke Kart and Kårhus, Line Lund and Diederichsen, Axel and Frimodt-Møller, Marie and Linneberg, Allan}},
issn = {{2044-6055}},
keywords = {{Calcium & bone; CARDIOLOGY; General endocrinology; NUTRITION & DIETETICS}},
language = {{eng}},
number = {{5}},
publisher = {{BMJ Publishing Group}},
series = {{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}},
url = {{http://dx.doi.org/10.1136/bmjopen-2023-071885}},
doi = {{10.1136/bmjopen-2023-071885}},
volume = {{13}},
year = {{2023}},
}