NCT07409623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 8, 2026

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

hemodialysis transplant candidates

To determine the prevalence of vitamin D deficiency and insufficiency

Diagnostic Test: VITAMIN D LEVEL

healthy living donors

To determine the prevalence of vitamin D deficiency and insufficiency

Diagnostic Test: VITAMIN D LEVEL

Interventions

VITAMIN D LEVELDIAGNOSTIC_TEST

To determine the prevalence of vitamin D deficiency and insufficiency

Also known as: VITAMIN D
healthy living donorshemodialysis transplant candidates

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nooshin Dalili

Tehran, 1666663421, Iran

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D Response Element

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Response ElementsEnhancer Elements, GeneticRegulatory Sequences, Nucleic AcidBase SequenceMolecular StructureBiochemical PhenomenaChemical PhenomenaPromoter Regions, GeneticGenetic StructuresGenetic PhenomenaRegulatory Elements, TranscriptionalGene ComponentsGenesGenome ComponentsGenome

Study Officials

  • SBMU SBMU

    SMBU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nephrology

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 13, 2026

Study Start

February 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations