Inhibit Progression of Coronary Artery Calcification with Vitamin K1 in Hemodialysis participants: iPACK HD Study.
Research Question: Does Vitamin K1 supplementation thrice weekly reduce the progression of coronary artery calcification (measured by CAC score) over 12 months in HD participants with a baseline CAC score of ≥ 30AUs?
Study Design: A randomized controlled double blinded pilot study.
Setting: Kingston General Hospital Renal Unit and/or affiliated satellite dialysis units.
Study Population: 50 end-stage kidney disease participants who have recently started hemodialysis and are new to receiving treatment.
Study Intervention: Participants will be randomized to receive Vitamin K1 treatment or placebo. Following randomization, study treatment (or placebo) will be started no more than four weeks after the date of CAC score results. Therapy will continue three times a week for 12 months. The treating clinician and coordinator will remain blinded during the study but the pharmacy will be unblinded to the participant's randomization in order that they may prepare the treatment interventions.
Outcomes: Participants will be followed monthly for up to 12 months or until study exit, whichever comes first. We will record admission and discharge dates to hospital. We will use the blood specimens to measure biomarkers of Vitamin K1.
Study status: Recruiting
Significance: This program of research represents a significant change in the way HD participants with coronary artery calcifications are managed. The supplementation of Vitamin K1 in participants with CKD may reduce the mortality and morbidity experienced by this high risk population that lives with chronic health problems related to vascular disease. This program of research has the potential to change practice and may improve the survival of HD participants.
This trial is registered at ClinicalTrials.gov (NCT01528800).
Dr. Rachel Holden, Principal Investigator
Jennifer Korol, Project Leader