Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

ConditionVitamin D Deficiency Due to Chronic Kidney Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMedical University of Gdansk

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D < 30 ng/mL)

Disqualifiers

dialysis time of less than 3 months

inadequately controled secondary hyperparathyroidism (iPTH>800pg/mL)

treatment with calcimimetics

treatment with active forms of vitamin D3,

Trial population

Patients will be recruited in Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Cholecalciferol
Drug
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.

Treatment groups

160 Participants

are divided into 3 treatment groups

Group A: 25(OH)D < 30 ng/mL1 intervention

Group B: 25(OH)D 30 - 49.9 ng/mL1 intervention

Group C: 25(OH)D 50-80 ng/mL1 intervention

Trial outcomes

Primary outcomes

efficacy and safety of cholecalciferol therapy in dialysed patients

analysis of - vitamin D levels - 25(OH)D, 1,25(OH)2D, calcium-phosphate metabolism parameters (serum calcium, phosphate, PTH levels),FGF23, GDF15 levels, in 3 groups of patients achieving different range of 25(OH)D levels

Time frame

2022-2026

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Gdansk

Lead sponsor

Source ClinicalTrials.gov

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