- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335593
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
Status
Completed
Conditions
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.
Sponsor
Collaborators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHCL394
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.
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