NCT07409623

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 552 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VITAMIN D LEVEL	To determine the prevalence of vitamin D deficiency and insufficiency

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2026-02-13
• Last updated: 2026-02-18

Locations

1 site across 1 country: Iran