Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• 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 sites (1)

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