Vitamin D DeficiencyNCT07409623
Vitamin D Status in Hemodialysis Transplant Candidates and Living Donors
An observational study of Vitamin D Deficiency, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- VITAMIN D LEVEL
- How many people
- 552 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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: * Age * Sex Group Variable: • Clinical status (hemodialysis transplant candidate vs living donor).
Who may be able to join
- Hemodialysis patients listed for kidney transplantation.
- Healthy living kidney donors.
Who cannot join
- NO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- VITAMIN D LEVEL
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITAMIN D LEVELDiagnostic test
Also called VITAMIN D
To determine the prevalence of vitamin D deficiency and insufficiency
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis transplant candidates | To determine the prevalence of vitamin D deficiency and insufficiency Receives: Diagnostic Test: VITAMIN D LEVEL | |
| healthy living donors | To determine the prevalence of vitamin D deficiency and insufficiency Receives: Diagnostic Test: VITAMIN D LEVEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline(Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2025
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- SBMU SBMU, Principal investigator, SMBU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409623
- Sponsor's protocol ID
- SBMU-12-1404/2
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07409623
- Acronym / sponsor ID
- SBMU-12-1404/2
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodialysis transplant candidates | – | Diagnostic Test: VITAMIN D LEVELTo determine the prevalence of vitamin D deficiency and insufficiency |
| healthy living donors | – | Diagnostic Test: VITAMIN D LEVELTo determine the prevalence of vitamin D deficiency and insufficiency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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: * Age * Sex Group Variable: • Clinical status (hemodialysis transplant candidate vs living donor).
Key inclusion criteria (2 listed)
- Hemodialysis patients listed for kidney transplantation.
- Healthy living kidney donors.
Key exclusion criteria (1 listed)
- NO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VITAMIN D LEVELAlso: VITAMIN DTo determine the prevalence of vitamin D deficiency and insufficiency | Diagnostic test | healthy living donors, hemodialysis transplant candidates |
Primary outcome
Prevalence of 25 hydroxyvitamin D deficiency and insufficiency
Time frame: Baseline(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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SBMU SBMU principal investigator
SMBU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of 25 hydroxyvitamin D deficiency and insufficiency (time frame: Baseline(Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.