Atherosclerosis is a disease of the arteries and is the result of various factors such as high blood cholesterol or diabetes, which lead to accumulations of fats, cells, and calcium deposits (i.e. plaques). It has been shown that people with a rapid increase in the amount of calcium deposits have a higher risk for stroke and heart attack than people with a decreased amount.
Previous scientific research has shown that a protein called Matrix Gla Protein plays an important role in the prevention of calcification. This protein works well only if there is enough Vitamin K in the blood vessels. In a large human studies, it has been shown that especially MK-7 (a form of Vitamin K2) is best absorbed by blood vessels. Moreover, studies suggest positive effects of vitamin D (especially D3) on vitamin K-dependent metabolism.
Over the last years, fluorine-18 sodium fluoride (18F-NaF) positron emission tomography (PET) emerged as a reliable clinical imaging tool able to detect micro-calcification in the blood vessels. Therefore, the present study will use 18F-NaF PET in combination with magnetic resonance imaging (MRI) to assess the influence of vitamin K and D supplementation in the development of arterial micro-calcification in the context of atherosclerosis.
The present study would like to confirm that MK-7 and vitamin D3 supplementation induces a significant reduction in the degree of micro-calcification from carotid artery disease patients, when comparing to a placebo, after 3 months.
This will be a prospective double blind randomised controlled feasibility study, in which one group will receive a MK-7 and vitamin D3 supplementation compared to a control group receiving a placebo.
Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease Carotid Artery Disease | Dietary Supplement: MK-7 and vitamin D3 Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | One group will receive a MK-7 and vitamin D3 supplementation and the control group will receive a placebo. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Vitamin K2 and D3 Supplementation on 18F-NaF PET/MRI in Patients With Carotid and Coronary Artery Disease |
Estimated Study Start Date : | August 1, 2021 |
Estimated Primary Completion Date : | January 1, 2023 |
Estimated Study Completion Date : | April 1, 2023 |
Arm | Intervention/treatment |
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Experimental: MK-7 and vitamin D3 supplementation
Patients will receive a daily MK-7 and vitamin D3 supplementation for 3 months.
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Dietary Supplement: MK-7 and vitamin D3
Patients will receive 400 micro-grams of Menaquinone-7 and 80 micro-grams of vitamin D3 per day.
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Placebo Comparator: Placebo
Patients will receive a daily placebo for 3 months.
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Other: Placebo
Patients will receive a placebo each day.
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Investigating whether MK-7 and vitamin D3 supplementation can diminish, halt or even reverse the development of arterial micro-calcification in the coronary arteries, measured as a difference between the intervention group and placebo group in coronary artery calcification score after the 3 months.
The Agatston coronary artery calcification score isis a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an non-contrast low-dose CT scan. The score ranges from 0 arbitrary units to > 400. The higher the value of the score, the higher the degree of calcification is in the coronary arteries; hence, lower values usually represent a better outcome.
The correlation between the uptake of (18)F-NaF at 3 months and the coronary artery calcification score.
The Agatston coronary artery calcification score isis a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an non-contrast low-dose CT scan. The score ranges from 0 arbitrary units to > 400. The higher the value of the score, the higher the degree of calcification is in the coronary arteries; hence, lower values usually represent a better outcome.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Felix M Mottaghy, MD, PhD | +31 43 3874746 | felix.mottaghy@mumc.nl | |
Contact: Alexandru Florea, MD | +49 241 80 89584 | aflorea@ukaachen.de |
Principal Investigator: | Felix M Mottaghy, MD, PhD | Maastricht University Medical Center |
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | July 1, 2019 | ||||||||||||
First Posted Date ICMJE | July 8, 2019 | ||||||||||||
Last Update Posted Date | February 15, 2021 | ||||||||||||
Estimated Study Start Date ICMJE | August 1, 2021 | ||||||||||||
Estimated Primary Completion Date | January 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
The change in time of vascular micro-calcification via (18)F-NaF PET/MRI [ Time Frame: 3 months follow-up ] The primary outcome of this study is the mean rate of the change in time of vascular micro-calcification in the carotid arteries, measured as a difference between the intervention group and placebo group in (18)F-NaF uptake via hybrid PET/MRI after the 3 months of treatment.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
The influence of MK-7 and vitamin D3 supplementation on carotid intima-media thickness [ Time Frame: baseline vs 3 months follow-up ] Investigating whether MK-7 and vitamin D3 supplementation can influence the carotid intima-media thickness
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Original Other Pre-specified Outcome Measures |
The influence of vitamin K2 supplementation on carotid intima-media thickness [ Time Frame: baseline vs 3 months follow-up ] Investigating whether vitamin K2 supplementation can influence the carotid intima-media thickness
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Descriptive Information | |||||||||||||
Brief Title ICMJE | Effects of VitamIN K2 and D3 supplementaTion on PET/MRI in Carotid Artery Disease | ||||||||||||
Official Title ICMJE | Effects of Vitamin K2 and D3 Supplementation on 18F-NaF PET/MRI in Patients With Carotid and Coronary Artery Disease | ||||||||||||
Brief Summary |
Atherosclerosis is a disease of the arteries and is the result of various factors such as high blood cholesterol or diabetes, which lead to accumulations of fats, cells, and calcium deposits (i.e. plaques). It has been shown that people with a rapid increase in the amount of calcium deposits have a higher risk for stroke and heart attack than people with a decreased amount. Previous scientific research has shown that a protein called Matrix Gla Protein plays an important role in the prevention of calcification. This protein works well only if there is enough Vitamin K in the blood vessels. In a large human studies, it has been shown that especially MK-7 (a form of Vitamin K2) is best absorbed by blood vessels. Moreover, studies suggest positive effects of vitamin D (especially D3) on vitamin K-dependent metabolism. Over the last years, fluorine-18 sodium fluoride (18F-NaF) positron emission tomography (PET) emerged as a reliable clinical imaging tool able to detect micro-calcification in the blood vessels. Therefore, the present study will use 18F-NaF PET in combination with magnetic resonance imaging (MRI) to assess the influence of vitamin K and D supplementation in the development of arterial micro-calcification in the context of atherosclerosis. The present study would like to confirm that MK-7 and vitamin D3 supplementation induces a significant reduction in the degree of micro-calcification from carotid artery disease patients, when comparing to a placebo, after 3 months. This will be a prospective double blind randomised controlled feasibility study, in which one group will receive a MK-7 and vitamin D3 supplementation compared to a control group receiving a placebo. |
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Detailed Description | Not Provided | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: One group will receive a MK-7 and vitamin D3 supplementation and the control group will receive a placebo. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||||||
Estimated Enrollment ICMJE |
52 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date ICMJE | April 1, 2023 | ||||||||||||
Estimated Primary Completion Date | January 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04010578 | ||||||||||||
Other Study ID Numbers ICMJE | NL69450.068.19 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Felix Mottaghy, Academisch Ziekenhuis Maastricht | ||||||||||||
Study Sponsor ICMJE | Academisch Ziekenhuis Maastricht | ||||||||||||
Collaborators ICMJE | Horizon 2020 - European Commission | ||||||||||||
Investigators ICMJE |
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PRS Account | Academisch Ziekenhuis Maastricht | ||||||||||||
Verification Date | February 2021 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |