Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT01612403
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2012-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2012-06-01', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'high molecular weight zinc binding protein', 'timeFrame': 'at the end of three months', 'description': 'elevated levels of high molecular weight zinc binding protein to normal value'}], 'secondaryOutcomes': [{'measure': 'qualitative semen parameters', 'timeFrame': 'at the end of three months', 'description': 'Volume of semen, progressive sperm motility percentage and total normal sperm count increased after zinc sulfate supplementation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['zinc binding protein'], 'conditions': ['Asthenozoospermia']}, 'referencesModule': {'references': [{'pmid': '23145537', 'type': 'DERIVED', 'citation': 'Hadwan MH, Almashhedy LA, Alsalman AR. Oral zinc supplementation restores high molecular weight seminal zinc binding protein to normal value in Iraqi infertile men. BMC Urol. 2012 Nov 13;12:32. doi: 10.1186/1471-2490-12-32.'}]}, 'descriptionModule': {'briefSummary': 'There are several causes leading to male infertility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands (LMW). The present study was conducted to study the effect of Zn supplementation on the quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels in semen of patients with asthenozoospmia.', 'detailedDescription': 'Elevation of ROS levels lead to an increase the oxidation of HMW-Zn binding proteins in seminal plasma of asthenozoospermic subjects. Zinc supplementation restores HMW-Zn% in seminal plasma of asthenozoospermic subjects to normal value. LMW-Zn% is elevated in seminal plasma of asthenozoospermic patients. It may be because increment the levels of semenogelin in seminal plasma of asthenozoospermic subjects. Zinc supplementation elevates LMW-Zn% in seminal plasma of asthenozoospermic subjects to more than normal value, this may be because of its enhancement of the synthesis of metallothioneins (Low molecular weight zinc binding protein).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '27 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes 37 subfertile male partners from couples who had consulted the infertility clinic of the Babil hospital of maternity (Hilla city/ IRAQ).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criteria were the presence of asthenozoospermia in the semen sample.\n\nExclusion Criteria:\n\n* the absence of endocrinopathy,\n* varicocele, and\n* 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': 'NCT01612403', 'acronym': 'supplement', 'briefTitle': 'Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen', 'organization': {'class': 'OTHER', 'fullName': 'Babylon University'}, 'officialTitle': 'Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen', 'orgStudyIdInfo': {'id': 'babil-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single group', 'description': 'Single group: all participants receive same intervention throughout study (Non-randomised)', 'interventionNames': ['Dietary Supplement: zinc sulfate']}], 'interventions': [{'name': 'zinc sulfate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['infertility'], 'description': 'every participant took two capsules of zinc sulfate per day for three months (each one 220mg)', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'IQ', 'city': 'Hillah', 'state': 'Muḩāfaz̧at Bābil', 'country': 'Iraq', 'facility': 'Babylon university/ college of science', 'geoPoint': {'lat': 32.46367, 'lon': 44.41963}}, {'zip': 'IQ', 'city': 'Hillah', 'state': 'Muḩāfaz̧at Bābil', 'country': 'Iraq', 'facility': 'Babylon University', 'geoPoint': {'lat': 32.46367, 'lon': 44.41963}}], 'overallOfficials': [{'name': 'mahmoud H. hadwan, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'babylon university / Iraq'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mahmoud hussein hadwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'mahmoud hussein hadwan', 'investigatorAffiliation': 'Babylon University'}}}}