Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

Recruiting

• Conditions: Vitamin D Deficiency Due to Chronic Kidney Disease
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT06571344
• Lead Sponsor: Medical University of Gdansk

Brief 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.

Detailed Description

The analysis will involve data obtained from medical records of dialysis patients who receive standard procedures consistent with national and international guidelines for specialized care.

Specifically, we will analyze the levels of:

* 25(OH)D,

* 1,25(OH)2D

* Calcium

* Phosphates

* PTH

* FGF23

* GDF15 to assess the efficacy and safety of cholecalciferol in dialysis patients.

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
25(OH)D < 30 ng/mL	Cholecalciferol	Dialysed patients with vitamin D level (25(OH)D) \< 30 ng/mL administered cholecalciferol
25(OH)D 30 - 49.9 ng/mL	Cholecalciferol	Dialysed patients with vitamin D level (25(OH)D) 30-49.9 ng/mL administered cholecalciferol
25(OH)D 50-80 ng/mL	Cholecalciferol	Dialysed patients with vitamin D level (25(OH)D) 50-80 ng/mL administered cholecalciferol

Primary Outcome Measures

Name	Time	Method
efficacy and safety of cholecalciferol therapy in dialysed patients	2022-2026	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

Trial Locations

Locations (1)

Medical University of Gdansk; 🇵🇱 Gdańsk, Poland