Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-03-15 @ 4:40 AM
Study NCT ID:
NCT05174793
Status:
COMPLETED
Last Update Posted:
2022-01-03
First Post:
2021-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Urine Color as a Marker of Hydration Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005440', 'term': 'Fluid Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-13', 'size': 60582, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-13T12:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'urine color was measured during dehydration and rehydration'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'can urine color expressed in CIE color space reflect hydration status', 'timeFrame': 'one hour dehydration and rehydration', 'description': 'urine color expressed in CIE color space'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dehydration']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space', 'detailedDescription': 'The study will examine if urine color expressed in CIE color space can reflect hydration status. Hydration staus will be rapidly altered via exercise in the heat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-35 years of age,\n* no previous heat intolerance\n\nExclusion Criteria:\n\n\\- Pregnant women,'}, 'identificationModule': {'nctId': 'NCT05174793', 'briefTitle': 'Using Urine Color as a Marker of Hydration Status', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Urine Color Expressed in CIE L*a*b* Colorspace During Rapid Changes in Hydration Status', 'orgStudyIdInfo': {'id': 'ENS1'}, 'secondaryIdInfos': [{'id': '0146', 'type': 'OTHER', 'domain': 'SDSU IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dehydration to rehydration', 'description': 'subjects were rehydrated following 2% dehydration', 'interventionNames': ['Other: dehydration and rehydration']}, {'type': 'EXPERIMENTAL', 'label': 'euhydration to dehydration', 'description': 'subjects were dehydrated by 2% with exercise in the heat', 'interventionNames': ['Other: dehydration and rehydration']}], 'interventions': [{'name': 'dehydration and rehydration', 'type': 'OTHER', 'description': 'dehydration and rehydration', 'armGroupLabels': ['dehydration to rehydration', 'euhydration to dehydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92120-1805', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Michael Buono', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael J. Buono', 'investigatorAffiliation': 'San Diego State University'}}}}