search
Back to results

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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Zinc Sulphate
Corn Starch filled Hard Gel Capsules
Epoetin alfa 2000-4000 IU solution for injection
Iron Hydroxide Saccharate Complex Solution for injection
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis patients, Zinc, Anemia, Oxidative stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Urology and Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zinc group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
at baseline and after 3 monthes.

Secondary Outcome Measures

Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)
Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase at baseline and after 3 monthes.
Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)
Measurement of C-Reactive protein and Interleukin-6 at baseline and after 3 monthes.
Effect on Fatigue (Fatigue Sevrity Scale)
Using Fatigue Sevrity Scale at baseline and after 3 monthes.

Full Information

First Posted
December 31, 2014
Last Updated
January 18, 2020
Sponsor
Ain Shams University
Collaborators
National Institute of Urology and Nephrology
search

1. Study Identification

Unique Protocol Identification Number
NCT02335593
Brief Title
Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients
Official Title
Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
National Institute of Urology and Nephrology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hemodialysis patients, Zinc, Anemia, Oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc Sulphate
Intervention Description
Zinc Sulphate Hard Gel capsules 110mg
Intervention Type
Other
Intervention Name(s)
Corn Starch filled Hard Gel Capsules
Intervention Description
Corn Starch filled Hard Gel Capsules
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa 2000-4000 IU solution for injection
Intervention Description
Epoetin alfa 2000-4000 IU solution for injection
Intervention Type
Drug
Intervention Name(s)
Iron Hydroxide Saccharate Complex Solution for injection
Intervention Description
Iron Hydroxide Saccharate Complex Solution for injection
Primary Outcome Measure Information:
Title
Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
Description
at baseline and after 3 monthes.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)
Description
Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase at baseline and after 3 monthes.
Time Frame
three months
Title
Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)
Description
Measurement of C-Reactive protein and Interleukin-6 at baseline and after 3 monthes.
Time Frame
three months
Title
Effect on Fatigue (Fatigue Sevrity Scale)
Description
Using Fatigue Sevrity Scale at baseline and after 3 monthes.
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasha R. El-kady, Bachelor
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Urology and Nephrology
City
Cairo
State/Province
El Matareya
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs