Effects of VitamIN K2 and D3 supplementaTion on PET/MRI in Carotid Artery Disease

NCT04010578 | Unknown

• 1 other identifier: NL69450.068.19
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months follow-up

Secondary Outcomes (3)

• The change in time of vascular calcification via coronary artery calcification score

  3 months follow-up

• The correlation between (18)F-NaF PET/MRI and coronary artery calcification score

  3 months follow-up

• The influence of MK-7 and vitamin D3 supplementation on MRI parameters

  baseline vs 3 months follow-up

Other Outcomes (1)

• The influence of MK-7 and vitamin D3 supplementation on carotid intima-media thickness

  baseline vs 3 months follow-up

Study Arms (2)

MK-7 and vitamin D3 supplementation

EXPERIMENTAL

Patients will receive a daily MK-7 and vitamin D3 supplementation for 3 months.

Dietary Supplement: MK-7 and vitamin D3

Placebo

PLACEBO COMPARATOR

Patients will receive a daily placebo for 3 months.

Other: Placebo

Interventions

MK-7 and vitamin D3 DIETARY_SUPPLEMENT

Patients will receive 400 micro-grams of Menaquinone-7 and 80 micro-grams of vitamin D3 per day.

MK-7 and vitamin D3 supplementation

Placebo OTHER

Patients will receive a placebo each day.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years
• Signed informed consent provided

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead
• Horizon 2020 - European Commission: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Carotid Artery Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Felix M Mottaghy, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix M Mottaghy, MD, PhD

CONTACT

+31 43 3874746; felix.mottaghy@mumc.nl

Alexandru Florea, MD

CONTACT

+49 241 80 89584; aflorea@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Model Details: One group will receive a MK-7 and vitamin D3 supplementation and the control group will receive a placebo.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 8, 2019
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• 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.