Vitamin D Status in Hemodialysis Transplant Candidates an... | NCT07409623

Studies
Vitamin D Status in Hemodialysis Transplant Candidates and Living Donors

NCT07409623

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Feb 18, 2026Actual

Enrollment

552Actual

Phase

Not provided

Conditions

Vitamin D Deficiency

Interventions

VITAMIN D LEVEL

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

Jan 1, 2026Actual

Completion Date

Feb 1, 2026Actual

First Submitted Date

Feb 8, 2026

First Submission Date that Met QC Criteria

Feb 8, 2026

First Posted Date

Feb 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nooshin dalili, Associate Professor of Nephrology, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

552Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VITAMIN D LEVEL	Diagnostic Test	To determine the prevalence of vitamin D deficiency and insufficiency	healthy living donors hemodialysis transplant candidates

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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:

Group Variable:

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
SBMU SBMU	SMBU	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nooshin Dalili		Tehran		1666663421	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D030181	Vitamin D Response Element

Ancestor Terms

ID	Term
D020218	Response Elements
D004742	Enhancer Elements, Genetic
D012045	Regulatory Sequences, Nucleic Acid
D001483	Base Sequence

Browse Leaves

Not provided

Browse Branches

Not provided