Relationship Between Serum Vitamin D and Atherosclerosis in Hemodialysis Patients

NCT ID: NCT07200804

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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

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Serum Vitamin D Atherosclerosis Hemodialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group A

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

Measurement of Serum Vitamin D Level

Intervention Type 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 B

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

Measurement of Carotid Intima-Media Thickness

Intervention Type 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)

Interventions

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Measurement of Serum Vitamin D Level

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).

Intervention Type DIAGNOSTIC_TEST

Measurement of Carotid Intima-Media Thickness

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)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ashraf Hassan

Assistant Professor of Internal Medicine and Nephrology, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MSO 2/2025

Identifier Type: -

Identifier Source: org_study_id

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