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Not yet recruitingNCT07109778Updated Aug 7, 2025

Copper to Zinc Ratio in End Stage Renal Disease Patients Outcome

An observational study in ESRD (End Stage Renal Disease) and Control Condition, sponsored by Minia University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Minia University · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

End-stage renal disease (ESRD) carries high morbidity and mortality due to cardiovascular complications, highlighting the need for ongoing research. Trace elements as copper (Cu), and zinc (Zn), are essential for physiological functions, enzyme activity, metabolism, and immune defense. In ESRD patients, Cu and Zn imbalances, with a higher Cu/Zn ratio are linked to greater cardiovascular problems. The relationship between the Cu/Zn ratio and clinical outcomes in ESRD needs more exploration

02

Conditions studied

  • ESRD (End Stage Renal Disease)
  • Control Condition
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In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 867 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion criteria

  • ESRD patients including those on maintenance HD

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • ESRD patients

    100 patients on maintainance hemodialysis

  • Control groub

    50 Healthy individuals

06

What researchers measure

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.

    Time frame: 6-8 months

07

Study locations

1 site
  • Nephrology and urology hospital, Minia unersity hospital, Faculty of medicine, Minia university
    Minya, Egypt
    • Shima Hassan Hamdy, MD of Internal medicine · Contact
08

References and documents

Publications

  • Xie Y, Liu F, Zhang X, Jin Y, Li Q, Shen H, Fu H, Mao J. Benefits and risks of essential trace elements in chronic kidney disease: a narrative review. Ann Transl Med. 2022 Dec;10(24):1400. doi: 10.21037/atm-22-5969. PubMed 36660676 ↗
  • Ruiz-Cabello P, Soriano-Maldonado A, Delgado-Fernandez M, Alvarez-Gallardo IC, Segura-Jimenez V, Estevez-Lopez F, Camiletti-Moiron D, Aparicio VA. Association of Dietary Habits with Psychosocial Outcomes in Women with Fibromyalgia: The al-Andalus Project. J Acad Nutr Diet. 2017 Mar;117(3):422-432.e1. doi: 10.1016/j.jand.2016.09.023. Epub 2016 Nov 24. PubMed 27890478 ↗
  • 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. PubMed 19414839 ↗
  • 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. PubMed 16004657 ↗
  • 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. PubMed 33373482 ↗
  • 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/ PubMed 36810043 ↗
  • 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. PubMed 32668647 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07109778
Lead sponsor
Minia University
Responsible party
Kerolles Adel Estawrow Saleh (Resident physician, Minia University) — Principal investigator
First posted
Aug 7, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Feb 1, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Aug 7, 2025

Study contacts

Kerolles Adel Estawrow Saleh, MBChB
Contact
Kerolesadel1997@gmail.com
01227657867

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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