Completed

NCT Number: NCT07409623

Vitamin D Status in Hemodialysis Transplant Candidates and Living Donors

Vitamin D, beyond its classical role in calcium and phosphate metabolism, is recognized as an important regulator of immune function and inflammation. Vitamin D deficiency is highly prevalent among patients with chronic kidney disease (CKD), particularly those receiving maintenance hemodialysis, and has been associated with adverse outcomes including mineral and bone disorders, increased susceptibility to infections, chronic inflammation, cardiovascular complications, and higher mortality.

Despite the availability of international data, comprehensive local evidence in Iran comparing vitamin D status between hemodialysis patients listed for kidney transplantation and healthy living kidney donors is limited. This study aims to determine and compare serum 25-hydroxyvitamin D [25(OH)D] levels in these two groups and to evaluate their association with demographic characteristics, selected immunologic and inflammatory indicators, and clinical outcomes.

This single-center cross-sectional analytical study will utilize data extracted from medical records. The results may provide scientific evidence to improve screening, prevention, and management strategies for vitamin D deficiency in hemodialysis patients awaiting kidney transplantation.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nooshin Dalili

Tehran, 1666663421, Iran

About this study

Study Design: Single-center, cross-sectional descriptive-analytical study.

Data Source: Retrospective extraction of medical records.

Study Groups:

Hemodialysis patients listed for kidney transplantation.
Healthy living kidney donors.

Main Study Variable:

Serum 25-hydroxyvitamin D [25(OH)D].

Demographic Variables:

Group Variable:

Clinical status (hemodialysis transplant candidate vs living donor).

Statistical Analysis:

Data will be analyzed using SPSS software. Continuous variables will be compared using independent t-test (two groups) or ANOVA (if multiple subgroups are analyzed). Regression analysis will be performed to evaluate predictors of serum 25(OH)D levels and its association with relevant clinical variables. Statistical significance will be defined as P < 0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Hemodialysis patients listed for kidney transplantation.
Healthy living kidney donors.

Exclusion criteria

Treatment and study plan

Vitamin D Level

Diagnostic Test

To determine the prevalence of vitamin D deficiency and insufficiency

Other names: VITAMIN D

Primary outcomes

Prevalence of 25 hydroxyvitamin D deficiency and insufficiency

Time frame: Baseline(Day 1)

proportion of participants with 25-hydroxyvitamin D deficiency (<20ng/ml)and insufficiency (20-29 ng/ml)based on serum 25-hydroxyvitamin D concentration measured by laboratory assay.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Serum Vitamin D Status in Hemodialysis Patients Listed for Kidney Transplantation and Healthy Living Kidney Donors and Its Association With Demographic, Immunologic, and Clinical Outcomes: A Single-Center Analytical Study

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Feb 13, 2026
Registry last updated: Feb 18, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed