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

January 18, 2020 updated by: Rasha Roshdy Ibrahim El-kady, Ain Shams University

Evaluation of the Effect of Zinc Supplementation on the Health Status of 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • El Matareya
      • Cairo, El Matareya, Egypt
        • National institute of urology and nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc group
Zinc Sulphate Hard Gel Capsules 110 mg once daily for three months plus Epoetin alfa 2000-4000 IU solution for injection andIron Hydroxide Saccharate Complex Solution for injection.
Zinc Sulphate Hard Gel capsules 110mg
Epoetin alfa 2000-4000 IU solution for injection
Iron Hydroxide Saccharate Complex Solution for injection
Active Comparator: Placebo group
Corn starch filled Hard Gel capsules once daily plus 'Epoetin alfa 2000-4000 IU solution for injection and Iron Hydroxide Saccharate Complex Solution for injection.
Epoetin alfa 2000-4000 IU solution for injection
Iron Hydroxide Saccharate Complex Solution for injection
Corn Starch filled Hard Gel Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three months
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.
three months
Effect on Fatigue (Fatigue Sevrity Scale)
Time Frame: three months
Using Fatigue Sevrity Scale at baseline and after 3 monthes.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rasha R. El-kady, Bachelor, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 18, 2020

Last Verified

January 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Zinc Sulphate

3
Subscribe