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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Zinc Sulphate

Intervention Type DIETARY_SUPPLEMENT

Zinc Sulphate Hard Gel capsules 110mg

Epoetin alfa 2000-4000 IU solution for injection

Intervention Type DRUG

Epoetin alfa 2000-4000 IU solution for injection

Iron Hydroxide Saccharate Complex Solution for injection

Intervention Type DRUG

Iron Hydroxide Saccharate Complex Solution for injection

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.

Group Type ACTIVE_COMPARATOR

Corn Starch filled Hard Gel Capsules

Intervention Type OTHER

Corn Starch filled Hard Gel Capsules

Epoetin alfa 2000-4000 IU solution for injection

Intervention Type DRUG

Epoetin alfa 2000-4000 IU solution for injection

Iron Hydroxide Saccharate Complex Solution for injection

Intervention Type DRUG

Iron Hydroxide Saccharate Complex Solution for injection

Interventions

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Zinc Sulphate

Zinc Sulphate Hard Gel capsules 110mg

Intervention Type DIETARY_SUPPLEMENT

Corn Starch filled Hard Gel Capsules

Intervention Type OTHER

Epoetin alfa 2000-4000 IU solution for injection

Intervention Type DRUG

Iron Hydroxide Saccharate Complex Solution for injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No