Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01431118
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2011-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron Metabolism in Dragon Boat Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-21', 'studyFirstSubmitDate': '2011-08-31', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from Baseline in prohepcidin after performing dragonboating', 'timeFrame': 'pre and post exercise intervention at the same day', 'description': 'one meassurement of prohepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day'}], 'secondaryOutcomes': [{'measure': 'haematocrit', 'timeFrame': 'pre and post exercise intervention at the same day', 'description': 'one meassurement of haematocrit immediate before and within three hours after performing two to four specific dragonboat intervention at the same day'}, {'measure': 'value of reticulocytes', 'timeFrame': 'pre exercise', 'description': 'one meassurement of reticulocytes immediate before performing two to four specific dragonboat interventions'}, {'measure': 'value of hypochromic erythrocytes', 'timeFrame': 'pre exercise', 'description': 'one meassurement of hypochromic erythrocytes immediate before performing two to four specific dragonboat interventions'}, {'measure': 'change from Baseline in serum iron after performing dragonboating', 'timeFrame': 'pre and post exercise intervention at the same day', 'description': 'one meassurement of serum iron immediate before and within three hours after performing two to four specific dragonboat interventions at the same day'}, {'measure': 'value of transferrin', 'timeFrame': 'pre exercise', 'description': 'one meassurement of transferrin immediate before performing two to four specific dragonboat interventions'}, {'measure': 'value of transferrin saturation', 'timeFrame': 'pre exercise', 'description': 'one meassurement of transferrin saturation immediate before performing two to four specific dragonboat interventions'}, {'measure': 'value of ferritin', 'timeFrame': 'pre exercise', 'description': 'one meassurement of ferritin immediate before performing two to four specific dragonboat interventions'}, {'measure': 'change from Baseline in hepcidin after performing dragonboating', 'timeFrame': 'pre and post exercise intervention at the same day', 'description': 'one meassurement of hepcidin immediate before and within three hours after performing two to four specific dragonboat interventions at the same day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['iron metabolism', 'hepcidin', 'dragon boating', 'sport-specific stress', 'iron', 'anaemia', 'sport'], 'conditions': ['Anaemia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is:\n\n* To investigate the effect of sport-specific stress in the iron metabolism of dragon boat athletes\n* To investigate the effects of sport-specific stress in the activity of pro-hepcidin and hepcidin', 'detailedDescription': 'This investigation evaluates the effects of sport-specific stress in iron metabolism of dragon boat athletes. Recent studies showed a significant increase in hepcidin activity under exercise (Röcker L. et al.(2005): Iron regulatory protein hepcidin is increased in female athletes after a marathon. European Journal of Applied Physiology, S. 95, 569-571)which possibly influences the iron metabolism.\n\nIn particular in this investigation the activity of pro-hepcidin and hepcidin under sport-specific stress is analysed. Therefore elite dragonboat athletes will be included to this study. Every athlete is tested once. At one exercise day from every athlete the iron metabolism especially the change of hepcidin, prohepcidin and iron before and after a specific dragonboat intervention is analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* athletes performing dragon boat sport\n\nExclusion Criteria:\n\n* acute clinically significant intercurrent diseases'}, 'identificationModule': {'nctId': 'NCT01431118', 'briefTitle': 'Iron Metabolism in Dragon Boat Athletes', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Iron Metabolism in Dragon Boat Athletes - An Analysis of Changes in Blood Count Parameters Under Sport-specific Stress', 'orgStudyIdInfo': {'id': 'Gi-02-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sports intervention male', 'description': 'male athletes of the german national dragon boat team', 'interventionNames': ['Other: specific dragon boating training intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sports intervention women', 'description': 'women athletes of the german national dragon boat team', 'interventionNames': ['Other: specific dragon boat intervention']}], 'interventions': [{'name': 'specific dragon boating training intervention', 'type': 'OTHER', 'description': 'male athletes of the german national dragon boat team performing three specific training units at one day', 'armGroupLabels': ['sports intervention male']}, {'name': 'specific dragon boat intervention', 'type': 'OTHER', 'description': 'women athletes of the german national dragon boat team performing two specific training units and one weight lifting test at one day', 'armGroupLabels': ['sports intervention women']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andree Hillebrecht, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of sportsmedicine- University Giessen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'MVZ für Laboratoriumsmedizin Koblenz', 'class': 'UNKNOWN'}, {'name': 'Deutscher Drachenboot Verband e.V.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med.', 'investigatorFullName': 'Andree Hillebrecht', 'investigatorAffiliation': 'University of Giessen'}}}}