TY - JOUR
T1 - Study protocol of the InterVitaminK trial
T2 - 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
AU - Kampmann, Freja Bach
AU - Thysen, Sanne Marie
AU - Nielsen, Camilla Friis Bryde
AU - Kofoed, Klaus Fuglsang
AU - Køber, Lars
AU - Pham, Michael Huy Cuong
AU - Vaag, Allan
AU - Jørgensen, Niklas Rye
AU - Petersen, Janne
AU - Jacobsen, Rikke Kart
AU - Kårhus, Line Lund
AU - Diederichsen, Axel
AU - Frimodt-Møller, Marie
AU - Linneberg, Allan
PY - 2023/5/19
Y1 - 2023/5/19
N2 - 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.
AB - 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.
KW - Male
KW - Humans
KW - Female
KW - Vitamin K
KW - Bone Density
KW - Vitamin K 2/pharmacology
KW - Lung
KW - Coronary Artery Disease/drug therapy
KW - Vascular Calcification/prevention & control
KW - Dietary Supplements
KW - Denmark
KW - Double-Blind Method
KW - Randomized Controlled Trials as Topic
U2 - 10.1136/bmjopen-2023-071885
DO - 10.1136/bmjopen-2023-071885
M3 - Journal article
C2 - 37208133
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e071885
ER -