Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-24 @ 4:18 AM
Study NCT ID:
NCT02335593
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2014-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019287', 'term': 'Zinc Sulfate'}, {'id': 'D000068817', 'term': 'Epoetin Alfa'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017967', 'term': 'Zinc Compounds'}, {'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-18', 'studyFirstSubmitDate': '2014-12-31', 'studyFirstSubmitQcDate': '2015-01-09', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)', 'timeFrame': 'three months', 'description': 'at baseline and after 3 monthes.'}], 'secondaryOutcomes': [{'measure': 'Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)', 'timeFrame': 'three months', 'description': 'Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase at baseline and after 3 monthes.'}, {'measure': 'Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)', 'timeFrame': 'three months', 'description': 'Measurement of C-Reactive protein and Interleukin-6 at baseline and after 3 monthes.'}, {'measure': 'Effect on Fatigue (Fatigue Sevrity Scale)', 'timeFrame': 'three months', 'description': 'Using Fatigue Sevrity Scale at baseline and after 3 monthes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis patients', 'Zinc', 'Anemia', 'Oxidative stress'], 'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Under regular hemodialysis for at least 6 months.\n* Clinically stable condition as outpatients.\n* Zinc-deficient patients (plasma Zinc concentrations less than 80 mcg/dl).\n\nExclusion Criteria:\n\n* 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.\n* Patients receiving Al hydroxide phosphate binders.\n* Hospitalization in the previous month before the onset of the trial, or having active infection.\n* Patients with malabsorption diseases (e.g, Crohn's disease), liver diseases, cancers, mental retardation, dementia or psychiatric illness."}, 'identificationModule': {'nctId': 'NCT02335593', 'briefTitle': 'Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'PHCL394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc group', 'description': '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.', 'interventionNames': ['Dietary Supplement: Zinc Sulphate', 'Drug: Epoetin alfa 2000-4000 IU solution for injection', 'Drug: Iron Hydroxide Saccharate Complex Solution for injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo group', 'description': "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.", 'interventionNames': ['Other: Corn Starch filled Hard Gel Capsules', 'Drug: Epoetin alfa 2000-4000 IU solution for injection', 'Drug: Iron Hydroxide Saccharate Complex Solution for injection']}], 'interventions': [{'name': 'Zinc Sulphate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc Sulphate Hard Gel capsules 110mg', 'armGroupLabels': ['Zinc group']}, {'name': 'Corn Starch filled Hard Gel Capsules', 'type': 'OTHER', 'description': 'Corn Starch filled Hard Gel Capsules', 'armGroupLabels': ['Placebo group']}, {'name': 'Epoetin alfa 2000-4000 IU solution for injection', 'type': 'DRUG', 'description': 'Epoetin alfa 2000-4000 IU solution for injection', 'armGroupLabels': ['Placebo group', 'Zinc group']}, {'name': 'Iron Hydroxide Saccharate Complex Solution for injection', 'type': 'DRUG', 'description': 'Iron Hydroxide Saccharate Complex Solution for injection', 'armGroupLabels': ['Placebo group', 'Zinc group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'El Matareya', 'country': 'Egypt', 'facility': 'National Institute of Urology and Nephrology', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Rasha R. El-kady, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Urology and Nephrology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Rasha Roshdy Ibrahim El-kady', 'investigatorAffiliation': 'Ain Shams University'}}}}