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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335593
• Other study ID #: PHCL394
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• Zinc Sulphate
Zinc Sulphate Hard Gel capsules 110mg

Other:
• Corn Starch filled Hard Gel Capsules
Corn Starch filled Hard Gel Capsules

Drug:
• Epoetin alfa 2000-4000 IU solution for injection
Epoetin alfa 2000-4000 IU solution for injection
• Iron Hydroxide Saccharate Complex Solution for injection
Iron Hydroxide Saccharate Complex Solution for injection

Locations

Country	Name	City	State
Egypt	National Institute of Urology and Nephrology	Cairo	El Matareya

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	National Institute of Urology and Nephrology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)	at baseline and after 3 monthes.	three months
Secondary	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.	three months
Secondary	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.	three months
Secondary	Effect on Fatigue (Fatigue Sevrity Scale)	Using Fatigue Sevrity Scale at baseline and after 3 monthes.	three months