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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02335593

Enrollment

Registered

2015-01-12

Start date

2014-12-31

Completion date

2015-11-30

Last updated

2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Hemodialysis patients, Zinc, Anemia, Oxidative stress

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.

Interventions

DIETARY_SUPPLEMENTZinc Sulphate

Zinc Sulphate Hard Gel capsules 110mg

OTHERCorn Starch filled Hard Gel Capsules

Corn Starch filled Hard Gel Capsules

DRUGEpoetin alfa 2000-4000 IU solution for injection

Epoetin alfa 2000-4000 IU solution for injection

DRUGIron Hydroxide Saccharate Complex Solution for injection

Iron Hydroxide Saccharate Complex Solution for injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026