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| Name | Class |
|---|---|
| National Institute of Urology and Nephrology | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc group | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Sulphate | Dietary Supplement | Zinc Sulphate Hard Gel capsules 110mg |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasha R. El-kady, Bachelor | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Urology and Nephrology | Cairo | El Matareya | Egypt |
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| Corn Starch filled Hard Gel Capsules |
| Other |
Corn Starch filled Hard Gel Capsules |
|
| Epoetin alfa 2000-4000 IU solution for injection | Drug | Epoetin alfa 2000-4000 IU solution for injection |
|
| Iron Hydroxide Saccharate Complex Solution for injection | Drug | Iron Hydroxide Saccharate Complex Solution for injection |
|
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 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| D000068817 | Epoetin Alfa |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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