Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT03361618
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2017-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053627', 'term': 'Asthenozoospermia'}], 'ancestors': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019287', 'term': 'Zinc Sulfate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Semen volume after treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.', 'timeFrame': 'up to three months.', 'description': 'Clinical parameter'}], 'secondaryOutcomes': [{'measure': 'Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.', 'timeFrame': 'up to three months.', 'description': 'Enzyme'}, {'measure': 'Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.', 'timeFrame': 'up to three months.', 'description': 'Enzyme'}, {'measure': "Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.", 'timeFrame': 'up to three months.', 'description': 'Enzyme'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uric acid', 'Adenosine deaminase', 'Zinc Sulfate', "5'-nucleotidase", 'Asthenospermia.', 'Xanthine oxidase'], 'conditions': ['Infertility Unexplained']}, 'referencesModule': {'references': [{'pmid': '31710193', 'type': 'DERIVED', 'citation': "Alsalman ARS, Almashhedy LA, Alta'ee AH, Hadwan MH. Effect of Zinc Supplementation on Urate Pathway Enzymes in Spermatozoa and Seminal Plasma of Iraqi Asthenozoospermic Patients: A Randomized Controlled Trial. Int J Fertil Steril. 2020 Jan;13(4):315-323. doi: 10.22074/ijfs.2020.5760. Epub 2019 Nov 11."}]}, 'descriptionModule': {'briefSummary': 'Although many reports have investigated the relationship between subfertility and uric acid levels in semen, to the best of author knowledge, there is no study have been published to yet focus on the effects of asthenospermia treatments, such as given an oral zinc supplementation, on the activity of urate-related enzymes, which are important in fertility of human.', 'detailedDescription': 'The present study was designed to investigate the effect of zinc supplementation on the qualitative and quantitative characteristics of semen, along with uric acid levels and urate-related enzymes in the seminal plasma and spermatozoa of asthenospermic males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '26 Years', 'genderBased': True, 'genderDescription': 'Male that undergo the presence of asthenozoospermia in the semen sample.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of asthenozoospermia in the semen sample.\n* Must be unable to reproduce.\n\nExclusion Criteria:\n\n* the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.'}, 'identificationModule': {'nctId': 'NCT03361618', 'briefTitle': 'Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway', 'organization': {'class': 'OTHER', 'fullName': 'Babylon University'}, 'officialTitle': 'Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway in Spermatozoa and Seminal Plasma of Iraqi Asthenospermic Patients', 'orgStudyIdInfo': {'id': 'Babil-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc sulfate', 'description': '60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).', 'interventionNames': ['Dietary Supplement: Zinc Sulfate']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control', 'description': '60 fertile (age 31.6±3.3 year) men, no treatment.'}], 'interventions': [{'name': 'Zinc Sulfate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).', 'armGroupLabels': ['Zinc sulfate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51002', 'city': 'Hillah', 'state': 'Babylon', 'country': 'Iraq', 'facility': 'Mahmoud Hussein Hadwan', 'geoPoint': {'lat': 32.46367, 'lon': 44.41963}}], 'overallOfficials': [{'name': 'Abdul Razzaq A. Alsalman, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Babyblon'}, {'name': 'Lamia A. Almashhedy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Babyblon'}, {'name': 'Mahmoud Hussein Hadwan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Babyblon'}, {'name': "Abdulsamie H Alta'ee, PhD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Babyblon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Babylon University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Iraq', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Dr. Mahmoud Hussein Hadwan', 'investigatorFullName': 'mahmoud hussein hadwan', 'investigatorAffiliation': 'Babylon University'}}}}