Clinical trial NCT06571344: Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
Official title: Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vitamin D Deficiency Due to Chronic Kidney Disease
Keywords: vitamin D
cholecalciferol
25-hydroxycholecalciferol
parathyroid hormone
FGF23
GDF15
chronic kidney disease-mineral and bone disorder
dialysis
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited in Department of Nephrology Transplantology and Internal Medicine, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: efficacy and safety of cholecalciferol therapy in dialysed patients
timeFrame: 2022-2026
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
Study officials:
affiliation: Medical University of Gdansk
name: Leszek Tylicki, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pludowski P, Takacs I, Boyanov M, Belaya Z, Diaconu CC, Mokhort T, Zherdova N, Rasa I, Payer J, Pilz S. Clinical Practice in the Prevention, Diagnosis and Treatment of Vitamin D Deficiency: A Central and Eastern European Expert Consensus Statement. Nutrients. 2022 Apr 2;14(7):1483. doi: 10.3390/nu14071483.
citation: Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.