Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients
- Conditions
- End Stage Renal Disease
- Interventions
- Dietary Supplement: Zinc SulphateOther: Corn Starch filled Hard Gel CapsulesDrug: Epoetin alfa 2000-4000 IU solution for injection
- Registration Number
- NCT02335593
- Lead Sponsor
- Ain Shams University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Under regular hemodialysis for at least 6 months.
- Clinically stable condition as outpatients.
- Zinc-deficient patients (plasma Zinc concentrations less than 80 mcg/dl).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zinc group Zinc Sulphate 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. Zinc group Epoetin alfa 2000-4000 IU solution for injection 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. Placebo group Corn Starch filled Hard Gel Capsules 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. Placebo group Epoetin alfa 2000-4000 IU solution for injection 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. Placebo group Iron Hydroxide Saccharate Complex Solution for injection 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. Zinc group Iron Hydroxide Saccharate Complex Solution for injection 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
National Institute of Urology and Nephrology
🇪🇬Cairo, El Matareya, Egypt