NCT06571344

Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency Due to Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Cholecalciferol	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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Poland