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

Launched by ACADEMISCH ZIEKENHUIS MAASTRICHT · Jul 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two supplements, Vitamin K2 (specifically MK-7) and Vitamin D3, on patients with carotid artery disease, a condition where arteries become narrowed due to plaque build-up. The researchers want to see if taking these vitamins can help reduce the amount of calcium deposits in the arteries, which could lower the risk of serious heart problems like strokes or heart attacks. The study will use advanced imaging techniques (PET and MRI) to measure changes in the arteries after three months of supplementation compared to a placebo group that will not receive the vitamins.

To participate in this trial, you need to be at least 18 years old and have asymptomatic carotid artery disease, meaning you have narrowing in your arteries but do not currently have any symptoms. However, certain conditions, like recent use of specific medications or a history of serious heart problems, may exclude you from joining. If you qualify, you will be randomly assigned to receive either the vitamin supplements or a placebo, and you can expect to attend follow-up visits to monitor your health and the effects of the treatment. This trial is not yet recruiting participants, but it aims to gather important information about how these vitamins can support heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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