Copper to Zinc Ratio in End Stage Renal Disease Patients Outcome

NCT ID: NCT07109778

Last Updated: 2025-08-07

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

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-04-01

Brief Summary

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

Detailed Description

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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

Conditions

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ESRD (End Stage Renal Disease) Control Condition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ESRD patients

100 patients on maintainance hemodialysis

No interventions assigned to this group

Control groub

50 Healthy individuals

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ESRD patients including those on maintenance HD

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Kerolles Adel Estawrow Saleh

Resident physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Minya, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Kerolles Adel Estawrow Saleh, MBChB

Role: CONTACT

01227657867

Facility Contacts

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Shima Hassan Hamdy, MD of Internal medicine

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 36660676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27890478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19414839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16004657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33373482 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 36810043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32668647 (View on PubMed)

Other Identifiers

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Copper to Zinc ratio in ESRD

Identifier Type: -

Identifier Source: org_study_id

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