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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25(OH)D < 30 ng/mL | Dialysed patients with vitamin D level (25(OH)D) < 30 ng/mL administered cholecalciferol |
| |
| 25(OH)D 30 - 49.9 ng/mL | Dialysed patients with vitamin D level (25(OH)D) 30-49.9 ng/mL administered cholecalciferol |
| |
| 25(OH)D 50-80 ng/mL | Dialysed patients with vitamin D level (25(OH)D) 50-80 ng/mL administered cholecalciferol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy and safety of cholecalciferol therapy in dialysed patients | 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 | 2022-2026 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited in Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leszek Tylicki, Prof. | Contact | + 48 58 584 47 00 | leszek.tylicki@gumed.edu.pl | |
| Agnieszka Tarasewicz, MD; PhD | Contact | ataras@gumed.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Leszek Tylicki, Prof. | Medical University of Gdansk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdansk | Recruiting | Gdansk | 80-211 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35406098 | Background | 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. | |
| 30675420 | Background |
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| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| 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. |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |