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Completed

NCT Number: NCT07200804

Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients

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.

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Key information

Conditions

Serum Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Hemodialysis Vascular Diseases Vitamin D

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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).

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)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Exploring the Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients: A Cross-sectional Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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