Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-16 @ 2:26 AM
Study NCT ID:
NCT02985905
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.', 'timeFrame': 'up to three months.'}], 'secondaryOutcomes': [{'measure': 'Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.', 'timeFrame': 'up to three months.'}, {'measure': 'Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.', 'timeFrame': 'up to three months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Zinc supplementation', 'Thiol', 'Glutathione peroxidase', 'Sulfhydryl oxidase'], 'conditions': ['Asthenozoospermia']}, 'referencesModule': {'references': [{'pmid': '29222649', 'type': 'DERIVED', 'citation': 'Alsalman ARS, Almashhedy LA, Hadwan MH. Effect of Oral Zinc Supplementation on the Thiol Oxido-Reductive Index and Thiol-Related Enzymes in Seminal Plasma and Spermatozoa of Iraqi Asthenospermic Patients. Biol Trace Elem Res. 2018 Aug;184(2):340-349. doi: 10.1007/s12011-017-1215-8. Epub 2017 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes activity which are important in fertility of the individual has been reported.', 'detailedDescription': 'The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with reduced thiol, oxidized thiol and thiol related enzymes in the seminal plasma of asthenospermic patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '26 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of asthenozoospermia in the semen sample.\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': 'NCT02985905', 'briefTitle': 'The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index', 'organization': {'class': 'OTHER', 'fullName': 'Babylon University'}, 'officialTitle': 'The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index and Thiol Related Enzymes in Spermatozoa of Iraqi Asthenospermic Patients', 'orgStudyIdInfo': {'id': 'Babil-4'}}, '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 Hadwan', 'geoPoint': {'lat': 32.46367, 'lon': 44.41963}}], 'overallOfficials': [{'name': 'Mahmoud Hadwan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Babylon University'}, {'name': 'L Almashhedy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Babylon University'}, {'name': 'Alsalman Abdulrrazaq, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Babylon University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'I plan to publish the results in a scientific journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mahmoud hussein hadwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Iraq', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'mahmoud hussein hadwan', 'investigatorAffiliation': 'Babylon University'}}}}