Copper to Zinc Ratio in End Stage Renal Disease Patients Outcome

NCT07109778 | Not Yet Recruiting

• 1 other identifier: Copper to Zinc ratio in ESRD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational clinical trial is to Study the impact of copper to zinc ratio on the outcome of ESRD patients

Conditions

ESRD (End Stage Renal Disease); Control Condition

Outcome Measures

Primary Outcomes (1)

• To determine whether an elevated serum Cu/Zn ratio is associated with an increased risk of cardiac complications in chronic hemodialysis patients.

  measuring serum Cu/Zn ratio and determining if it is associated with an increased risk of cardiac complications in chronic hemodialysis patients.

  6-8 months

Study Arms (2)

ESRD patients

100 patients on maintainance hemodialysis

Control groub

50 Healthy individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

this prospective observational Case control study will enroll a well-characterized cohort of 100 adult patients with ESRD(eGFR \<15 mL/min/1.73 m²) , including those undergoing maintenance hemodialysis recruited from nephrology clinics and dialysis unit at Minia University Hospital . The recruited patients will be stratified into two groups; 1. Dialysis ESRD Group: It will include 100 adult patients with ESRD stage 5D on maintenance hemodialysis for at least 6 months. 2. control groub study the impact of Cu/Zn ratio on outcomme of ESRD patients

You may qualify if:

• ESRD patients including those on maintenance HD

You may not qualify if:

• Acute kidney injury or rapidly progressive glomerulonephritis, acute infections or active inflammatory conditions as sepsis and autoimmune diseases, liver cirrhosis (Child-Pugh Class B or C), gastrointestinal disorders as inflammatory bowel disease, malabsorption, history of organ transplantation excluding kidney transplantation who may be included in a separate analysis if sufficient numbers are recruited, receiving total parenteral nutrition, Cu or Zn metabolism disorders as Wilson's disease, vitamin complex supplementation or antioxidants within the past 6 months, recent hospitalization within the past 3 months, recent surgery within 3 months, recent blood transfusion \< 3 months, Pregnancy or lactation, Malignancy.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Nephrology and urology hospital, Minia unersity hospital, Faculty of medicine, Minia university

Minya, Egypt

Location

Related Publications (7)

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  PMID: 36660676 BACKGROUND

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  PMID: 27890478 BACKGROUND

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

  PMID: 19414839 BACKGROUND

• Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

  PMID: 16004657 BACKGROUND

• Duerksen DR, Laporte M, Jeejeebhoy K. Evaluation of Nutrition Status Using the Subjective Global Assessment: Malnutrition, Cachexia, and Sarcopenia. Nutr Clin Pract. 2021 Oct;36(5):942-956. doi: 10.1002/ncp.10613. Epub 2020 Dec 29.

  PMID: 33373482 BACKGROUND

• Devlin N, Pickard S, Busschbach J. The Development of the EQ-5D-5L and its Value Sets. 2022 Mar 24. In: Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK589306/

  PMID: 36810043 BACKGROUND

• Cannas D, Loi E, Serra M, Firinu D, Valera P, Zavattari P. Relevance of Essential Trace Elements in Nutrition and Drinking Water for Human Health and Autoimmune Disease Risk. Nutrients. 2020 Jul 13;12(7):2074. doi: 10.3390/nu12072074.

  PMID: 32668647 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kerolles Adel Estawrow Saleh, MBChB

CONTACT

01227657867; Kerolesadel1997@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

EG (1)