Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

NCT06571344 | Recruiting

• 1 other identifier: NKBBN/783/2022
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

25(OH)D < 30 ng/mL

Dialysed patients with vitamin D level (25(OH)D) \< 30 ng/mL administered cholecalciferol

Drug: 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

Drug: Cholecalciferol

25(OH)D 50-80 ng/mL

Dialysed patients with vitamin D level (25(OH)D) 50-80 ng/mL administered cholecalciferol

Drug: Cholecalciferol

Interventions

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.

25(OH)D 30 - 49.9 ng/mL; 25(OH)D 50-80 ng/mL; 25(OH)D < 30 ng/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D \< 30 ng/mL)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk

Gdansk, 80-211, Poland

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Leszek Tylicki, Prof.

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leszek Tylicki, Prof.

CONTACT

+ 48 58 584 47 00; leszek.tylicki@gumed.edu.pl

Agnieszka Tarasewicz, MD; PhD

CONTACT

ataras@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

PL (1)