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

Study Overview
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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.

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

Conditions
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End Stage Renal Disease

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc group<br>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. | Dietary Supplement: Zinc Sulphate<br>* Zinc Sulphate Hard Gel capsules 110mg<br>Drug: Epoetin alfa 2000-4000 IU solution for injection<br>* Epoetin alfa 2000-4000 IU solution for injection<br>Drug: Iron Hydroxide Saccharate Complex Solution for injection<br>* Iron Hydroxide Saccharate Complex Solution for injection<br>|
| Active Comparator: Placebo group<br>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. | Other: Corn Starch filled Hard Gel Capsules<br>* Corn Starch filled Hard Gel Capsules<br>Drug: Epoetin alfa 2000-4000 IU solution for injection<br>* Epoetin alfa 2000-4000 IU solution for injection<br>Drug: Iron Hydroxide Saccharate Complex Solution for injection<br>* Iron Hydroxide Saccharate Complex Solution for injection<br>|

What is the study measuring?
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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) | 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) | 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) | Measurement of C-Reactive protein and Interleukin-6 at baseline and after 3 monthes. | three months | 
| Effect on Fatigue (Fatigue Sevrity Scale) | Using Fatigue Sevrity Scale at baseline and after 3 monthes. | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis patients, Zinc, Anemia, Oxidative stress