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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: End Stage Renal Disease

Treatments: Other: Corn Starch filled Hard Gel Capsules; Drug: Epoetin alfa 2000-4000 IU solution for injection; Dietary Supplement: Zinc Sulphate; Drug: Iron Hydroxide Saccharate Complex Solution for injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02335593

PHCL394

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Zinc group

Experimental group

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.

Treatment:

Drug: Epoetin alfa 2000-4000 IU solution for injection

Dietary Supplement: Zinc Sulphate

Drug: Iron Hydroxide Saccharate Complex Solution for injection

Placebo group

Active Comparator group

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.

Treatment:

Drug: Epoetin alfa 2000-4000 IU solution for injection

Other: Corn Starch filled Hard Gel Capsules

Drug: Iron Hydroxide Saccharate Complex Solution for injection