Vitamin D Deficiency Due to Chronic Kidney Disease
Conditions
Keywords
vitamin D, cholecalciferol, 25-hydroxycholecalciferol, parathyroid hormone, FGF23, GDF15, chronic kidney disease-mineral and bone disorder, dialysis
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.
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.
Sponsors
Medical University of Gdansk
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Poland
Contacts
Primary ContactLeszek Tylicki, Prof.
Backup ContactAgnieszka Tarasewicz, MD; PhD
Outcome results
None listed