RecruitingNCT06571344

Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management


Sponsor

Medical University of Gdansk

Enrollment

160 participants

Start Date

Nov 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D). The main question it aims to answer is: How does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D? Participants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates how best to diagnose and treat vitamin D deficiency in patients with stage 5 chronic kidney disease who are on dialysis. Low vitamin D is very common in dialysis patients and can contribute to bone disease, heart problems, and immune dysfunction. The study aims to find the safest and most effective vitamin D supplementation approach for this group. **You may be eligible if:** - You have stage 5 chronic kidney disease (end-stage kidney disease) and are currently on dialysis - Your vitamin D level (25-hydroxyvitamin D) is below 30 ng/mL (deficient or insufficient) **You may NOT be eligible if:** - You have been on dialysis for less than 3 months - Your parathyroid hormone levels are very high (above 800 pg/mL) and not well controlled - You are already taking calcimimetics or active vitamin D3 medications - You have had a parathyroid gland removal or both kidneys removed - You are on long-term corticosteroid treatment - You have not consented to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCholecalciferol

The patients with vitamin D (25(OH)D) levels \< 30 ng/mL, and 30-50 ng/ml will recieve a dose of cholecalciferol at 70,000 IU per week (20,000 IU + 20,000 IU + 30,000 IU per week). In the patients with 25(OH)D levels 50-80 ng/mL the dose of cholecalciferol will be adjusted to avoid exceeding the upper limit of the laboratory norm.


Locations(1)

Medical University of Gdansk

Gdansk, Poland

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NCT06571344