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

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 [(18)F]Fluoride (Na[(18)F]F) positron emission tomography (PET)/ mag...

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Autores principales: Florea, Alexandru, Kooi, M. Eline, Mess, Werner, Schurgers, Leon J., Bucerius, Jan, Mottaghy, Felix M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8003489/
https://www.ncbi.nlm.nih.gov/pubmed/33808652
http://dx.doi.org/10.3390/nu13030994
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author Florea, Alexandru
Kooi, M. Eline
Mess, Werner
Schurgers, Leon J.
Bucerius, Jan
Mottaghy, Felix M.
author_facet Florea, Alexandru
Kooi, M. Eline
Mess, Werner
Schurgers, Leon J.
Bucerius, Jan
Mottaghy, Felix M.
author_sort Florea, Alexandru
collection PubMed
description 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 [(18)F]Fluoride (Na[(18)F]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[(18)F]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[(18)F]F PET/MRI and CT scan. The primary endpoint is the change in Na[(18)F]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.
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spelling pubmed-80034892021-03-28 Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[(18)F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design Florea, Alexandru Kooi, M. Eline Mess, Werner Schurgers, Leon J. Bucerius, Jan Mottaghy, Felix M. Nutrients Article 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 [(18)F]Fluoride (Na[(18)F]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[(18)F]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[(18)F]F PET/MRI and CT scan. The primary endpoint is the change in Na[(18)F]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. MDPI 2021-03-19 /pmc/articles/PMC8003489/ /pubmed/33808652 http://dx.doi.org/10.3390/nu13030994 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ).
spellingShingle Article
Florea, Alexandru
Kooi, M. Eline
Mess, Werner
Schurgers, Leon J.
Bucerius, Jan
Mottaghy, Felix M.
Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[(18)F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design
title Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[(18)F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design
title_full Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[(18)F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design
title_fullStr Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[(18)F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design
title_full_unstemmed Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[(18)F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design
title_short Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[(18)F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design
title_sort effects of combined vitamin k2 and vitamin d3 supplementation on na[(18)f]f pet/mri in patients with carotid artery disease: the intricate rationale and trial design
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8003489/
https://www.ncbi.nlm.nih.gov/pubmed/33808652
http://dx.doi.org/10.3390/nu13030994
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