Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06250556
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine Supplementation for Female Football
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'pre-to-post design for experiment 2.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'kidney function', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'serum creatinine levels'}], 'secondaryOutcomes': [{'measure': 'kidney function', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'urinary creatinine levels'}, {'measure': 'kidney function', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'serum urea levels'}, {'measure': 'kidney function', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'serum sodium levels'}, {'measure': 'kidney function', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'serum potassium levels'}, {'measure': 'muscle damage', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'serum creatine kinase levels'}, {'measure': 'hemogram', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'platelet count'}, {'measure': 'hemogram', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'red blood cell count'}, {'measure': 'hemogram', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'white blood cell count'}, {'measure': 'hemogram', 'timeFrame': 'baseline and after the sport season (~12 months)', 'description': 'erythrocyte sedimentation rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Athletes']}, 'descriptionModule': {'briefSummary': 'Creatine is an effective, inexpensive, and safe dietary supplement, which has been largely used in sports and clinical populations. However, creatine is much less studied in female athletes, with long-term data being particularly scant. This study aims to expand our knowledge on the effects of creatine supplementation in young (Under-20) and elite female football players. This study will comprise two experiments. The first one will be a randomized, controlled trial in which young athletes will be assigned into either creatine or placebo (n = 20). Before and 7 days after supplementation or placebo (4 x 5 g/d of Creapure or dextrose at same dose), athletes will perform a battery of performance tests. Blood and urinary biochemical parameters for assessing the safety of supplementation will be analyzed (creatinine, albuminuria, urea, sodium, potassium, liver enzymes, creatine kinase, hematology). Food intake will be assessed by means of 3-d 24-h dietary recalls. The second experiment will have a quasi-experimental design (i.e., pre-to-post), in which both young and elite football players (n = 70) will be supplemented with creatine (4 x 5 g/d for 7 days and then 5 days during the follow-up) and will be assessed for safety using the above-mentioned markers during the regular football season (\\~12 months). Assessments will be carried out at baseline, in the mid-season and after the season.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female football players\n\nExclusion Criteria:\n\n* age under 18'}, 'identificationModule': {'nctId': 'NCT06250556', 'briefTitle': 'Creatine Supplementation for Female Football', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Creatine Supplementation in Young and Elite Female Football Players', 'orgStudyIdInfo': {'id': 'creatineforwomen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'creatine supplementation', 'interventionNames': ['Dietary Supplement: creatine']}], 'interventions': [{'name': 'creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'creatine supplementation (Creapure)', 'armGroupLabels': ['creatine supplementation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'Sao Paulo / SP', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Tiemi Saito', 'role': 'CONTACT', 'email': 'tiemisaito01@gmail.com', 'phone': '551130618789'}], 'facility': 'School of Medicine of the University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Bruno Gualano, PhD', 'role': 'CONTACT', 'email': 'gualano@usp.br', 'phone': '551126618022'}], 'facility': 'School of Medicine, University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Data will be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}