CompletedPhase 4

Effect of Vitamin K2 (MK7) on Cardiovascular and Bone Disease in Dialysis Patients

Denmark123 participantsStarted 2016-11

Plain-language summary

Cardiovascular disease (CVD) is the most frequent cause of death in patients (ptt.) with chronic kidney disease (CKD). Compared to the general population death due to CVD is 10-20 times higher in CKD ptt. being treated with hemodialysis. Vascular calcification and hence arterial stiffness is of great importance for the high incidence of CVD. CKD ptt. in dialysis treatment also have a 3 times higher risk of bone fractures. Both vertebral and other fractures of low energy are associated with a high mortality. Matrix Gla Protein (MGP) is an important inhibitor of vascular calcification and Osteocalcin (OC) is an important regulator of bone metabolism. The function of both MGP and OC depend on vitamin K. Vitamin K is supplied with food. The content is low in food recommended to CKD ptt. which is reflected in very low concentrations of vitamin K in their blood samples. A correlation between vitamin K level, incidence of vascular calcification and bone density has been proven; yet there are no trials elucidating the clinical effect of vitamin K on vascular calcification or bone strength. The investigators will conduct a randomized placebo controlled trial examining the clinical effects of vitamin K2 on vascular calcification and bone mineralization in order to prevent and treat CVD and bone disease in CKD ptt. Primary study endpoints: 1. Changes in arterial stiffness assessed by pulse wave examination 2. Changes in bone mineral density (BMD) in distal radius assessed by DXA-scans. Secondary study endpoints: Changes in coronary artery and valvular calcification assessed by heart-CT-scans, blood pressure, body composition, total and regional BMD, lateral column/aortic calcification score as well as a panel of correlating blood tests.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years old * Life expectancy \> 2 years * Written consent following oral information * Permanent treatment with dialysis ≥ 3 months with either peritoneal or hemodialysis Exclusion Criteria: * Treatment with vitamin K or vitamin K-antagonist by the beginning of the trial or 1 months within. * Chronic GI-malabsorption leading to a slower bowel transit (e.g. Celiac disease, Short bowel syndrome). * Ongoing malignancy (ongoing treatment/clinical controlled visits or diagnosed less than 5 years ago), excl. Non-Melanoma-Skin-Cancer (NMSC). * Abuse of alcohol or other euphoric drug. * Women who are pregnant or breast-feeding and women who are in the childbearing age without contraception. * Total/subtotal parathyroidectomy * Treatment with recombined PTH. * Treatment with bisphosphonates or other anti-osteoporotic drugs (Selective Estrogen Reuptake Modulators (SERM), strontium, renalat, denosumab). Only RenaKvit-kar (vessel): * Atrial fibrillation/other arrhythmia of significance * Aortic stenosis of significance * Agatston score \< 100 by heart-CT-scan * Bilateral upper arm fistula * Amputation above metatarsal level Criteria of withdrawal: * Kidney transplantation * Starting treatment with vitamin K-antagonists * Wish to with draw from the participant * Unacceptable side effect to ingestion of vitamin K or placebo * Reasonable suspicion of lacking compliance regarding medication

What they're measuring

For RenaKvit-vessel: Changes in arterial stiffness assessed by pulse wave examination reflecting vascular calcification (unit: m/s).

Timeframe: 2 years

For RenaKvit-bone: Changes in bone mineral density (BMD) in the distal radial bone (unit T-score).

Timeframe: 2 years

Trial details

NCT IDNCT02976246

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-26