Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cholecalciferol.
- Who it may be relevant to
- Registry conditions: Vitamin D Deficiency Due to Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- efficacy and safety of cholecalciferol therapy in dialysed patients [Time frame: 2022-2026]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Poland · 1 center
- Medical University of Gdansk — Gdansk
Publications
- 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. PMID 35406098
- 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. PMID 30675420
Identifiers
NCT: NCT06571344 · NKBBN/783/2022