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Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[18F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design

by 1,2,3, 2,3, 4, 3,5,6, 2,3,7,† and 1,2,3,*,†
1
Department of Nuclear Medicine, University Hospital RWTH Aachen, 52074 Aachen, Germany
2
Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands
3
School for Cardiovascular Diseases (CARIM), Maastricht University, 6229HX Maastricht, The Netherlands
4
Department of Clinical Neurophysiology, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands
5
Department of Biochemistry, Maastricht University, 6229HX Maastricht, The Netherlands
6
Institute of Experimental Medicine and Systems Biology, RWTH Aachen University, 52074 Aachen, Germany
7
Department of Nuclear Medicine, University of Göttingen, 37075 Göttingen, Germany
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editor: Vassilios Liakopoulos
Nutrients 2021, 13(3), 994; https://doi.org/10.3390/nu13030994
Received: 12 January 2021 / Revised: 13 March 2021 / Accepted: 17 March 2021 / Published: 19 March 2021
(This article belongs to the Section Clinical Nutrition)
INTRICATE is a prospective double-blind placebo-controlled feasibility study, assessing the influence of combined vitamin K2 and vitamin D3 supplementation on micro-calcification in carotid artery disease as imaged by hybrid Sodium [18F]Fluoride (Na[18F]F) positron emission tomography (PET)/ magnetic resonance imaging (MRI). Arterial calcification is an actively regulated process and results from the imbalance between calcification promoting and inhibiting factors. Considering the recent advancements in medical imaging, ultrasound (US), PET/MRI, and computed tomography (CT) can be used for the selection and stratification of patients with atherosclerosis. Fifty-two subjects with asymptomatic carotid artery disease on at least one side of the neck will be included in the study. At baseline, an Na[18F]F PET/MRI and CT examination will be performed. Afterwards, subjects will be randomized (1:1) to a vitamin K (400 µg MK-7/day) and vitamin D3 (80 µg/day) or to placebo. At the 3-month follow-up, subjects will undergo a second Na[18F]F PET/MRI and CT scan. The primary endpoint is the change in Na[18F]F PET/MRI (baseline vs. after 3 months) in the treatment group as compared to the placebo arm. Secondary endpoints are changes in plaque composition and in blood-biomarkers. The INTRICATE trial bears the potential to open novel avenues for future large scale randomized controlled trials to intervene in the plaque development and micro-calcification progression. View Full-Text
Keywords: cardiovascular diseases; positron emission tomography; magnetic resonance imaging; sodium fluoride; vitamin K; vitamin D; vascular calcification; micro-calcification cardiovascular diseases; positron emission tomography; magnetic resonance imaging; sodium fluoride; vitamin K; vitamin D; vascular calcification; micro-calcification
MDPI and ACS Style

Florea, A.; Kooi, M.E.; Mess, W.; Schurgers, L.J.; Bucerius, J.; Mottaghy, F.M. Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[18F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design. Nutrients 2021, 13, 994. https://doi.org/10.3390/nu13030994

AMA Style

Florea A, Kooi ME, Mess W, Schurgers LJ, Bucerius J, Mottaghy FM. Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[18F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design. Nutrients. 2021; 13(3):994. https://doi.org/10.3390/nu13030994

Chicago/Turabian Style

Florea, Alexandru, M. E. Kooi, Werner Mess, Leon J. Schurgers, Jan Bucerius, and Felix M. Mottaghy. 2021. "Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[18F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design" Nutrients 13, no. 3: 994. https://doi.org/10.3390/nu13030994

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