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

Vitamin D Deficiency Due to Chronic Kidney Disease

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

Inclusion Criteria1

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

Exclusion Criteria8

dialysis time of less than 3 months
inadequately controled secondary hyperparathyroidism (iPTH\>800pg/mL)
treatment with calcimimetics
treatment with active forms of vitamin D3,
parathyroidectomy
bilateral nephrectomy
treatment with corticosteroids
lack of consent to take part in the study.

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