Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency Due to Chronic Kidney Disease
• Intervention / Treatment: Drug: Cholecalciferol

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.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Leszek Tylicki, Prof.; Phone Number: + 48 58 584 47 00; Email: leszek.tylicki@gumed.edu.pl
• Study Contact Backup: Name: Agnieszka Tarasewicz, MD; PhD; Email: ataras@gumed.edu.pl

Study Locations

• Poland
  • Gdańsk, Poland, 80-211
    • Recruiting
    • Medical University of Gdansk
    • Contact: Tylcki Leszek, Prof.; Phone Number: +48 58 584 47 07; Email: leszek.tylicki@gumed.edu.pl
    • Contact: Agnieszka Tarasewicz, Md, PhD; Phone Number: +48 58 584 47 07; Email: ataras@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited in Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
25(OH)D < 30 ng/mL; Dialysed patients with vitamin D level (25(OH)D) < 30 ng/mL administered cholecalciferol	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.
25(OH)D 30 - 49.9 ng/mL; Dialysed patients with vitamin D level (25(OH)D) 30-49.9 ng/mL administered cholecalciferol	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.
25(OH)D 50-80 ng/mL; Dialysed patients with vitamin D level (25(OH)D) 50-80 ng/mL administered cholecalciferol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Leszek Tylicki, Prof., Medical University of Gdansk

Publications and helpful links

General 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.
• 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. Erratum In: Kidney Int Suppl (2011). 2017 Dec;7(3):e1. doi: 10.1016/j.kisu.2017.10.001.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: dialysis; vitamin D; parathyroid hormone; cholecalciferol; FGF23; chronic kidney disease-mineral and bone disorder; GDF15; 25-hydroxycholecalciferol
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: NKBBN/783/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No