Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients

NCT07200804 | Completed

• 1 other identifier: FMASU MSO 2/2025
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Serum; Vitamin D; Atherosclerosis; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Correlation between Serum Vitamin D and Atherosclerosis

  Correlation between Serum Vitamin D and Atherosclerosis was recorded.

  Immediately post-procedure (Up to 1 hour)

Study Arms (2)

Group A

Patients with normal carotid intima-media thickness (CIMT).

Diagnostic Test: Measurement of Serum Vitamin D Level

Group B

Patients with increased carotid intima-media thickness (CIMT).

Other: Measurement of Carotid Intima-Media Thickness

Interventions

Measurement of Serum Vitamin D Level DIAGNOSTIC_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).

Group A

Measurement of Carotid Intima-Media Thickness OTHER

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)

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with active infections, malignancies, autoimmune diseases, or pre-existing cardiovascular conditions.
• Pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine and Nephrology, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)