SerumNCT07200804
Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients
An observational study of Serum and Vitamin D, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aimed to check if there is a link between good vitamin D levels in the blood and subclinical atherosclerosis in people on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serum, Vitamin D, Atherosclerosis
- What is being tested?
- Measurement of Serum Vitamin D Level and Measurement of Carotid Intima-Media Thickness
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 2021
- 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: The present cross-sectional study was carried out on 90 patients with ESRD undergoing hemodialysis at Ain Shams University or the National Institute of Nephrology and Urology from June 2021 to December 2021.
Who may be able to join
- Patients with end-stage renal disease (ESRD) who had been on maintenance hemodialysis for at least 6 months.
- Age of 18 years or older.
- Patients receiving three weekly dialysis sessions using a bicarbonate-based dialysate with anticoagulants.
Who cannot join
- Patients with active infections, malignancies, autoimmune diseases, or pre-existing cardiovascular conditions.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients: A Cross-sectional Study
The study aimed to check if there is a link between good vitamin D levels in the blood and subclinical atherosclerosis in people on hemodialysis.
Read the detailed description
Hemodialysis patients with End-Stage Renal Disease (ESRD) face a significantly elevated risk of cardiovascular disease (CVD) due to a complex interplay of factors. A 30-year-old HD patient faces a cardiovascular mortality risk equivalent to that of an 80-year-old in the general population, emphasizing the accelerated aging of the cardiovascular system in ESRD.
Vitamin D may reduce inflammation and modulate immunity, lowering hypertension and dyslipidemia risks and possibly reversing vascular calcification. However, excessive supplementation can cause hypercalcemia.
- Conditions
- Serum, Vitamin D, Atherosclerosis, Hemodialysis
- Being tested
- Measurement of Serum Vitamin D Level, Measurement of Carotid Intima-Media Thickness
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Serum Vitamin D LevelDiagnostic test
Vitamin D is made of two types, named ergocalciferol (vitamin D2) and cholecalciferol (vitamin D3). Vitamin D2 is produced by converting ergosterol, a fungi and plants sterol, when it is exposed to light from the sun. Vitamin D3 is made differently, as it is formed in animal skin such as human skin with the help of 7-dehydrocholesterol when the skin is exposed to sunlight (UVB radiation).
Measurement of Carotid Intima-Media ThicknessOther
Samples were collected by measuring the carotid intima-media thickness (CIMT) with a Mind ray Real time ultrasound scanner DC-6 doppler machine that has a probe at a frequency of 7.5 MHz. The measurement was done from three different sites each 1 cm proximal to the carotid bulb. The average of three values was taken to determine the final value. If CIMT > 0.8 mm, it was defined as thickened. The measurements adhered to the Mannheim CIMT Consensus (2004-2006)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with normal carotid intima-media thickness (CIMT). Receives: Diagnostic Test: Measurement of Serum Vitamin D Level | |
| Group B | Patients with increased carotid intima-media thickness (CIMT). Receives: Other: Measurement of Carotid Intima-Media Thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Serum Vitamin D and Atherosclerosis
Correlation between Serum Vitamin D and Atherosclerosis was recorded.
Measured: Immediately post-procedure (Up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jun 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SerumStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200804
- Sponsor's protocol ID
- FMASU MSO 2/2025
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Abd El Mobdy AH, Saeed SA, Bichari WA, Osman OA, Salah SY. Exploring the relationship between serum vitamin D and atherosclerosis in hemodialysis patients: a cross-sectional study. Front Nephrol. 2026 Jun 10;6:1738155. doi: 10.3389/fneph.2026.1738155. eCollection 2026.
PubMed 42358669
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07200804
- Acronym / sponsor ID
- FMASU MSO 2/2025
- Conditions
- Serum, Vitamin D, Atherosclerosis, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Oct 2025 (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.
The study aimed to check if there is a link between good vitamin D levels in the blood and subclinical atherosclerosis in people on hemodialysis.
Detailed description
Hemodialysis patients with End-Stage Renal Disease (ESRD) face a significantly elevated risk of cardiovascular disease (CVD) due to a complex interplay of factors. A 30-year-old HD patient faces a cardiovascular mortality risk equivalent to that of an 80-year-old in the general population, emphasizing the accelerated aging of the cardiovascular system in ESRD.
Vitamin D may reduce inflammation and modulate immunity, lowering hypertension and dyslipidemia risks and possibly reversing vascular calcification. However, excessive supplementation can cause hypercalcemia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Measurement of Serum Vitamin D LevelPatients with normal carotid intima-media thickness (CIMT). |
| Group B | – | Other: Measurement of Carotid Intima-Media ThicknessPatients with increased carotid intima-media thickness (CIMT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present cross-sectional study was carried out on 90 patients with ESRD undergoing hemodialysis at Ain Shams University or the National Institute of Nephrology and Urology from June 2021 to December 2021.
Key inclusion criteria (3 listed)
- Patients with end-stage renal disease (ESRD) who had been on maintenance hemodialysis for at least 6 months.
- Age of 18 years or older.
- Patients receiving three weekly dialysis sessions using a bicarbonate-based dialysate with anticoagulants.
Key exclusion criteria (2 listed)
- Patients with active infections, malignancies, autoimmune diseases, or pre-existing cardiovascular conditions.
- Pregnancy.
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 |
|---|---|---|
| Measurement of Serum Vitamin D LevelVitamin D is made of two types, named ergocalciferol (vitamin D2) and cholecalciferol (vitamin D3). Vitamin D2 is produced by converting ergosterol, a fungi and plants sterol, when it is exposed to light from the sun. Vitamin D3 is made differently, as it is formed in animal skin such as human skin with the help of 7-dehydrocholesterol when the skin is exposed to sunlight (UVB radiation). | Diagnostic test | Group A |
| Measurement of Carotid Intima-Media ThicknessSamples were collected by measuring the carotid intima-media thickness (CIMT) with a Mind ray Real time ultrasound scanner DC-6 doppler machine that has a probe at a frequency of 7.5 MHz. The measurement was done from three different sites each 1 cm proximal to the carotid bulb. The average of three values was taken to determine the final value. If CIMT > 0.8 mm, it was defined as thickened. The measurements adhered to the Mannheim CIMT Consensus (2004-2006) | Other | Group B |
Primary outcome
Correlation between Serum Vitamin D and Atherosclerosis
Time frame: Immediately post-procedure (Up to 1 hour)
Correlation between Serum Vitamin D and Atherosclerosis was recorded.
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 1 Oct 2025.
- Derived from this study: PubMed 42358669Abd El Mobdy AH, Saeed SA, Bichari WA, Osman OA, Salah SY. Exploring the relationship between serum vitamin D and atherosclerosis in hemodialysis patients: a cross-sectional study. Front Nephrol. 2026 Jun 10;6:1738155. doi: 10.3389/fneph.2026.1738155. eCollection 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Serum and Vitamin D, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 2 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 1 Oct 2025. 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 Egypt. 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?
Correlation between Serum Vitamin D and Atherosclerosis (time frame: Immediately post-procedure (Up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07200804, which also lists 1 linked publication.
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 1 Oct 2025.