Vitamin D Status in Hemodialysis Transplant Candidates and Living Donors

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Diagnostic test: VITAMIN D LEVEL

Detailed Description

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:

• Age
• Sex

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.

• Study Type: Observational
• Enrollment (Actual): 552

Contacts and Locations

Study Locations

• Iran
  • Tehran, Iran, 1666663421
    • Nooshin Dalili

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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:

• Age
• Sex

Group Variable:

• Clinical status (hemodialysis transplant candidate vs living donor).

Description

Inclusion Criteria:

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

Exclusion Criteria:

NO

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hemodialysis transplant candidates; To determine the prevalence of vitamin D deficiency and insufficiency	Diagnostic test: VITAMIN D LEVEL; To determine the prevalence of vitamin D deficiency and insufficiency; Other Names: VITAMIN D
healthy living donors; To determine the prevalence of vitamin D deficiency and insufficiency	Diagnostic test: VITAMIN D LEVEL; To determine the prevalence of vitamin D deficiency and insufficiency; Other Names: VITAMIN D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of 25 hydroxyvitamin D deficiency and insufficiency	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.	Baseline(Day 1)

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Principal Investigator: SBMU SBMU, SMBU

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutritional and Metabolic Diseases; Vitamin D Deficiency; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Base Sequence; Gene Components; Genes; Response Elements; Enhancer Elements, Genetic; Regulatory Sequences, Nucleic Acid; Promoter Regions, Genetic; Regulatory Elements, Transcriptional; Vitamin D Response Element
• Other Study ID Numbers: SBMU-12-1404/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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