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NCT Number: NCT06571344

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. efficacy and safety of cholecalciferol therapy in dialysed patients

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka Tarasewicz, MD; PhD

CONTACT

[email protected]

Leszek Tylicki, Prof.

CONTACT

[email protected]

+ 48 58 584 47 00

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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