Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin D Deficiency Due to Chronic Kidney Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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25(OH)D < 30 ng/mL

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

Cholecalciferol

Intervention Type 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

Dialysed patients with vitamin D level (25(OH)D) 30-49.9 ng/mL administered cholecalciferol

Cholecalciferol

Intervention Type 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 50-80 ng/mL

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

Cholecalciferol

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No