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Not yet recruiting NCT07109778

Copper to Zinc Ratio in End Stage Renal Disease Patients Outcome

— Observational ESRD (End Stage Renal Disease) Control Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ESRD (End Stage Renal Disease), Control Condition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of Copper to Zinc Ratio on Outcome of End Stage Renal Disease Patients

Overview

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

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

Primary outcome measures

  • To determine whether an elevated serum Cu/Zn ratio is associated with an increased risk of cardiac complications in chronic hemodialysis patients. [Time frame: 6-8 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Egypt · 1 center
  • Nephrology and urology hospital, Minia unersity hospital, Faculty of medicine, Minia unive — Minya

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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/ PMID 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. PMID 32668647

Identifiers

NCT: NCT07109778 · Copper to Zinc ratio in ESRD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗