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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07409623
Enrollment
552
Registered
2026-02-13
Start date
2025-02-01
Completion date
2026-02-01
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Brief 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.

Interventions

DIAGNOSTIC_TESTVITAMIN D LEVEL

To determine the prevalence of vitamin D deficiency and insufficiency

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

NO

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of 25 hydroxyvitamin D deficiency and insufficiencyBaseline(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.

Countries

Iran

Contacts

PRINCIPAL_INVESTIGATORSBMU SBMU

SMBU

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026