Coronary Artery DiseaseINTRICATENCT04010578
Effects of VitamIN K2 and D3 supplementaTion on PET/MRI in Carotid Artery Disease
A study testing MK-7 and vitamin D3 in people with Coronary Artery Disease and Carotid Artery Disease, run by Academisch Ziekenhuis Maastricht.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Carotid Artery Disease
- What is being tested?
- MK-7 and vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asymptomatic carotid artery disease on at least one side with a degree of stenosis > 25% (according to on the ECST criteria). If the patient has a symptomatic carotid artery disease on the contra-lateral side, he/she will still be included in the study, if intensified medical treatment for this symptomatic stenosis (e.g. statins, antiplatelet medication) was started ≥ 6 month before inclusion of the patient. This protocol was chosen in order to widely assure a stable situation on the plaque(s), which avoids an overspill from this medication on the assumed effects of the MK-7 and vitamin D3 supplementation.
- Age older than 18 years
- Signed informed consent provided
Who cannot join
- Antiplatelet or cholesterol lowering medication started within the past 6 months
- Chronic or paroxysmal atrial fibrillation
- Presence or scheduled coronary or carotid revascularisation procedure (e.g. stent implantation, coronary artery bypass graft, balloon-dilatation, endarterectomy, angioplasty)
- History of myocardial infarction or stroke
- Malignant disease (except for treated basal-cell or squamous cell carcinoma)
- Use of vitamin K antagonists or any other anticoagulation treatment
Show all 18Show fewer
- A life-expectancy < 1 year
- Claustrophobia
- Presence of a pacemaker, intra-cardiac defibrillator, or metallic implant (e.g. vascular clip, neuro-stimulator, cochlear implant)
- Body weight > 130kg or body habitus that does not fit into the gantry
- Pregnancy or wish to become pregnant in the near future
- Breast feeding
- (History of) metabolic or gastrointestinal disease
- Use of vitamin K or D containing supplements or vitamin K-rich foods (i.e. soya)
- Chronic inflammatory disease
- Systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- Corticoid treatment
- Participation in a clinical study more recently than one month before the current study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Vitamin K2 and D3 Supplementation on 18F-NaF PET/MRI in Patients With Carotid and Coronary Artery Disease
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.
Read more
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.
- Conditions
- Coronary Artery Disease, Carotid Artery Disease
- Being tested
- MK-7 and vitamin D3, Placebo
- Keywords
- Vitamin K2, 18F-NaF, hybrid PET/MRI, Coronary artery calcification score, Menaquinone-7, Carotid Artery Disease, Coronary Artery Disease, Vitamin D3
- Medical subject headings
- Coronary Artery Disease, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-7 and vitamin D3Dietary supplement
Patients will receive 400 micro-grams of Menaquinone-7 and 80 micro-grams of vitamin D3 per day.
PlaceboOther
Patients will receive a placebo each day.
| Study group | Role | What they receive |
|---|---|---|
| MK-7 and vitamin D3 supplementation | Experimental | Patients will receive a daily MK-7 and vitamin D3 supplementation for 3 months. Receives: Dietary Supplement: MK-7 and vitamin D3 |
| Placebo | Placebo comparator | Patients will receive a daily placebo for 3 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: baseline vs 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive a MK-7 and vitamin D3 supplementation and the control group will receive a placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Responsible party
- Principal investigator, Felix Mottaghy, Academisch Ziekenhuis Maastricht
- Investigators
- Felix M Mottaghy, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010578
- Sponsor's protocol ID
- NL69450.068.19
- Acronym
- INTRICATE
- Status last verified
- Sep 2023
- First submitted
- 1 Jul 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin K2 and D3 Supplementation on 18F-NaF PET/MRI in Patients With Carotid and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04010578
- Acronym / sponsor ID
- INTRICATE / NL69450.068.19
- Conditions
- Coronary Artery Disease, Carotid Artery Disease
- Keywords
- Vitamin K2, 18F-NaF, hybrid PET/MRI, Coronary artery calcification score, Menaquinone-7, Carotid Artery Disease, Coronary Artery Disease, Vitamin D3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One group will receive a MK-7 and vitamin D3 supplementation and the control group will receive a placebo.
| Arm | Type | Receives |
|---|---|---|
| MK-7 and vitamin D3 supplementation | Experimental | Dietary Supplement: MK-7 and vitamin D3Patients will receive a daily MK-7 and vitamin D3 supplementation for 3 months. |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive a daily placebo for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Asymptomatic carotid artery disease on at least one side with a degree of stenosis > 25% (according to on the ECST criteria). If the patient has a symptomatic carotid artery disease on the contra-lateral side, he/she will still be included in the study, if intensified medical treatment for this symptomatic stenosis (e.g. statins, antiplatelet medication) was started ≥ 6 month before inclusion of the patient. This protocol was chosen in order to widely assure a stable situation on the plaque(s), which avoids an overspill from this medication on the assumed effects of the MK-7 and vitamin D3 supplementation.
- Age older than 18 years
- Signed informed consent provided
Key exclusion criteria (18 listed)
- Antiplatelet or cholesterol lowering medication started within the past 6 months
- Chronic or paroxysmal atrial fibrillation
- Presence or scheduled coronary or carotid revascularisation procedure (e.g. stent implantation, coronary artery bypass graft, balloon-dilatation, endarterectomy, angioplasty)
- History of myocardial infarction or stroke
- Malignant disease (except for treated basal-cell or squamous cell carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-7 and vitamin D3Patients will receive 400 micro-grams of Menaquinone-7 and 80 micro-grams of vitamin D3 per day. | Dietary supplement | MK-7 and vitamin D3 supplementation |
| PlaceboPatients will receive a placebo each day. | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
The change in time of vascular calcification via coronary artery calcification score
Time frame: 3 months follow-up
The correlation between (18)F-NaF PET/MRI and coronary artery calcification score
Time frame: 3 months follow-up
The influence of MK-7 and vitamin D3 supplementation on MRI parameters
Time frame: baseline vs 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix M Mottaghy, MD, PhD principal investigator
Maastricht University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing MK-7 and vitamin D3 in people with Coronary Artery Disease and Carotid Artery Disease, run by Academisch Ziekenhuis Maastricht.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix M Mottaghy, MD, PhD (+31 43 3874746, felix.mottaghy@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in time of vascular micro-calcification via (18)F-NaF PET/MRI (time frame: 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.