Effect of Vitamin K2 (MK7) on Cardiovascular and Bone Disease in Dialysis Patients (NCT02976246) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
For RenaKvit-vessel: Changes in arterial stiffness assessed by pulse wave examination reflecting vascular calcification (unit: m/s).
Timeframe: 2 years
2
For RenaKvit-bone: Changes in bone mineral density (BMD) in the distal radial bone (unit T-score).