Skip to main content
OpenTrials
Completed

NCT Number: NCT02335593

Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients

The purpose of the study is to evaluate the effect of Zinc supplementation on health status of hemodialysis patients through measurement of the following before and after Zinc administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also, Evaluation of quality of life of hemodialysis patients before and after Zinc administration using Fatigue severity scale questionnaire.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Renal Disease Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Urology and Nephrology

Cairo, El Matareya, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Under regular hemodialysis for at least 6 months.
  • Clinically stable condition as outpatients.
  • Zinc-deficient patients (plasma Zinc concentrations less than 80 mcg/dl).

Exclusion criteria

  • Patients taking any antioxidant supplements including vitamin E, Omega-3 fatty acids, green tea preparations or immunosuppressive medications within 2 months prior to enrollment in the study.
  • Patients receiving Al hydroxide phosphate binders.
  • Hospitalization in the previous month before the onset of the trial, or having active infection.
  • Patients with malabsorption diseases (e.g, Crohn's disease), liver diseases, cancers, mental retardation, dementia or psychiatric illness.

Treatment and study plan

Zinc Sulphate

Dietary Supplement

Zinc Sulphate Hard Gel capsules 110mg

Corn Starch filled Hard Gel Capsules

Other

Corn Starch filled Hard Gel Capsules

Epoetin alfa 2000-4000 IU solution for injection

Drug

Epoetin alfa 2000-4000 IU solution for injection

Iron Hydroxide Saccharate Complex Solution for injection

Drug

Iron Hydroxide Saccharate Complex Solution for injection

Primary outcomes

  1. Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)

    Time frame: three months

    at baseline and after 3 monthes.

Secondary outcomes

  1. Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)

    Time frame: three months

    Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase at baseline and after 3 monthes.

  2. Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)

    Time frame: three months

    Measurement of C-Reactive protein and Interleukin-6 at baseline and after 3 monthes.

  3. Effect on Fatigue (Fatigue Sevrity Scale)

    Time frame: three months

    Using Fatigue Sevrity Scale at baseline and after 3 monthes.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • National Institute of Urology and Nephrology

Registry information

Official study title

Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2015
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.