CompletedNot Applicable

Underlying Causes of Low Vitamin K Status in Hemodialysis Patients

Denmark33 participantsStarted 2018-02-22

Plain-language summary

Studies have shown that patients with chronic kidney disease in hemodialysis have a low vitamin K status which is believed to be related to an increased risk of atherosclerosis and increased bleeding tendency. The underlying causes of low vitamin K status in hemodialysis patients is unknown. Thus, the aim of this study is to investigate why hemodialysis patients have a low vitamin K status and how to improve it. This study is composed of five trials. Four of them are based on possible hypotheses to the low vitamin K status. The hypotheses are: 1. The daily intake of vitamin K is insufficient. 2. Vitamin K is removed from the blood during dialysis. 3. Absorption in the intestines is impaired. 4. The analysis method (dephosphorylated-uncarboxylated MGP) is influenced by the patients' protein intake. The purpose of the fifth trial is to investigate solutions to improve the vitamin K status of hemodialysis. One is to improve vitamin K status through diet with an increased focus on foods with high concentrations of vitamin K while considering phosphate, potassium and fluid restrictions. The second is to increase vitamin K status through a daily supplement of 360µg Menakinon-7.

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: * Chronic kidney disease * Hemodialysis (\> 3 months) at Herlev Hospital, Nephrological department * Understands and are able to read danish * Able to collaborate on diet etc. Exclusion Criteria: * Warfarin treatment * Pregnant or breastfeeding * Prior intake of vitamin K supplements * Short bowl disease, pancreatitis or other malabsorption diseases/syndromes * Dementia * Diabetes Mellitus (only an exclusion criterion in sub-trial 3: Absorption of vitamin K)

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

Δ-dp-uc-MGP (Sub-trial 5)

Timeframe: 15 weeks

Trial details

NCT IDNCT03493087

SponsorUniversity of Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-20

View on ClinicalTrials.gov More Renal Insufficiency, Chronic trials