A Phase 2 interventional study of Zinc Sulphate and Corn Starch filled Hard Gel Capsules in End Stage Renal Disease, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 64 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Epoetin alfa 2000-4000 IU solution for injection · Drug: 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.
Other: Corn Starch filled Hard Gel Capsules · Drug: Epoetin alfa 2000-4000 IU solution for injection · Drug: Iron Hydroxide Saccharate Complex Solution for injection
Zinc Sulphate Hard Gel capsules 110mg
Corn Starch filled Hard Gel Capsules
Epoetin alfa 2000-4000 IU solution for injection
Iron Hydroxide Saccharate Complex Solution for injection
Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
at baseline and after 3 monthes.
Time frame: three months
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.
Time frame: 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.
Time frame: three months
Effect on Fatigue (Fatigue Sevrity Scale)
Using Fatigue Sevrity Scale at baseline and after 3 monthes.
Time frame: three months
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Ain Shams University