An interventional study of MK-7 and vitamin D3 and Placebo in Coronary Artery Disease and Carotid Artery Disease, sponsored by Academisch Ziekenhuis Maastricht. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Academisch Ziekenhuis Maastricht · Not applicable, Interventional, and Treatment
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 52 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Academisch Ziekenhuis Maastricht is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive a daily MK-7 and vitamin D3 supplementation for 3 months.
Dietary Supplement: MK-7 and vitamin D3
Patients will receive a daily placebo for 3 months.
Other: Placebo
Drug pages: Menaquinone 7 · Cholecalciferol
Patients will receive 400 micro-grams of Menaquinone-7 and 80 micro-grams of vitamin D3 per day.
Patients will receive a placebo each day.
The change in time of vascular micro-calcification via (18)F-NaF PET/MRI
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.
Time frame: 3 months follow-up
The change in time of vascular calcification via coronary artery calcification score
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.
Time frame: 3 months follow-up
The correlation between (18)F-NaF PET/MRI and coronary artery calcification score
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.
Time frame: 3 months follow-up
The influence of MK-7 and vitamin D3 supplementation on MRI parameters
Investigating whether MK-7 and vitamin D3 supplementation can influence the fibrous cap status on the MRI.
Time frame: baseline vs 3 months follow-up
The influence of MK-7 and vitamin D3 supplementation on carotid intima-media thickness
Investigating whether MK-7 and vitamin D3 supplementation can influence the carotid intima-media thickness
Time frame: baseline vs 3 months follow-up
No study locations are listed for this record.
Plan to share: Yes — All IPD that underlie results in a publication will be shared.
Supporting information: Statistical analysis plan, Informed consent form
Time frame: IPD will be shared stating with 6 months after publication.
Access criteria: Access criteria will be discussed with all the study members, then it will be published.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Menaquinone 7 · Cholecalciferol
Academisch Ziekenhuis Maastricht