Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00755105
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2008-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Measurements of Body Iron Excretion of Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'janetrhunt@gmail.com', 'phone': '701-795-8353', 'title': 'Janet Hunt, PhD', 'organization': 'USDA Grand Forks Human Nutrition Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Male Subjects Having Consumed Iron-55 Tracer', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Menstruating Women Having Consumed Iron-55 Tracer', 'description': 'Includes women on hormonal contraceptives', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Postmenopausal Women Having Consumed Iron-55 Tracer', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Iron Excretion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Male Subjects Having Consumed Iron-55 Tracer'}, {'id': 'OG001', 'title': 'Menstruating Women Having Consumed Iron-55 Tracer', 'description': 'Includes women on hormonal contraceptives'}, {'id': 'OG002', 'title': 'Postmenopausal Women Having Consumed Iron-55 Tracer'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.25'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.30', 'upperLimit': '2.20'}, {'value': '1.08', 'groupId': 'OG002', 'lowerLimit': '0.73', 'upperLimit': '1.43'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '4 years', 'description': 'Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55', 'unitOfMeasure': 'milligrams per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Male Subjects Having Consumed Iron-55 Tracer'}, {'id': 'FG001', 'title': 'Menstruating Women Having Consumed Iron-55 Tracer', 'description': 'Includes women on hormonal contraceptives'}, {'id': 'FG002', 'title': 'Postmenopausal Women Having Consumed Iron-55 Tracer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were invited to join the study if they had participated in a study involving consumption of Iron-55 at least one year earlier at Grand Forks Human Nutrition Research Center', 'preAssignmentDetails': 'All enrolled participants were included'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Male Subjects Having Consumed Iron-55 Tracer'}, {'id': 'BG001', 'title': 'Menstruating Women Having Consumed Iron-55 Tracer', 'description': 'Includes women on hormonal contraceptives'}, {'id': 'BG002', 'title': 'Postmenopausal Women Having Consumed Iron-55 Tracer'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '8', 'groupId': 'BG000'}, {'value': '40', 'spread': '5', 'groupId': 'BG001'}, {'value': '50', 'spread': '5', 'groupId': 'BG002'}, {'value': '43', 'spread': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2008-09-16', 'resultsFirstSubmitDate': '2008-12-30', 'studyFirstSubmitQcDate': '2008-09-17', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-08', 'studyFirstPostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Iron Excretion.', 'timeFrame': '4 years', 'description': 'Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['body iron excretion', 'Iron isotopes'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '19386738', 'type': 'DERIVED', 'citation': 'Hunt JR, Zito CA, Johnson LK. Body iron excretion by healthy men and women. Am J Clin Nutr. 2009 Jun;89(6):1792-8. doi: 10.3945/ajcn.2009.27439. Epub 2009 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'This is an observation study of subjects who previously had iron-55 isotope administered in studies of iron absorption. By determining the retention of the isotope in blood during a 3-year period, body iron excretion can be measured.', 'detailedDescription': 'One year following initial administration of iron-55 as a part of other related studies, subjects provide blood samples every 6 months for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult men and women who previously participated in iron absorption studies using iron-55 isotope.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have taken iron-55 in previous study conducted by USDA Grand Forks Human Nutrition Research Center\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00755105', 'briefTitle': 'Measurements of Body Iron Excretion of Healthy Adults', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Body Iron Excretion of Healthy Adults as Measured by Isotope Dilution', 'orgStudyIdInfo': {'id': 'GFHNRC049'}}, 'contactsLocationsModule': {'locations': [{'zip': '58202', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Janet R Hunt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}