Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-28 @ 7:18 AM
Study NCT ID:
NCT03602404
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2018-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Morocco']}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Spot urine samples Dried blood spots'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1592}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated iodine intake', 'timeFrame': '17 months', 'description': 'Estimated daily iodine intake of the study population derived from urinary iodine and creatinine concentrations measured in spot urine samples'}], 'secondaryOutcomes': [{'measure': 'Urinary iodine concentration', 'timeFrame': '17 months', 'description': 'Measured in spot urine samples and 24 h urine collections'}, {'measure': 'Urinary creatinine concentration', 'timeFrame': '17 months', 'description': 'Measured in spot urine samples and 24 h urine collections'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iodine'], 'conditions': ['Iodine Deficiency']}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to develop a reliable method to obtain habitual iodine intakes from spot urinary iodine concentration (UIC) and to assess the prevalence of inadequate iodine intake in school-age children and women of reproductive age. We will evaluate different methods to estimate iodine intake from UIC and estimate the prevalence of inadequate and excess iodine intake in UIC studies conducted in populations with low, adequate and high iodine intakes using the the established estimated average requirement (EAR)/Tolerable Upper Intake Level (UL) cut-point method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Apparently healthy school-age children and women of reproductive age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lived in study area \\>= 12 months\n* no reported intake of Amiodarone\n* no history of thyroid dysfunction / goiter (past \\& present)\n* no exposure to iodine containing contrast agents within the last 12 months\n\nSecond arm: Women aged 18 - 49, exclusion / inclusion criteria apply, plus non-pregnant, non-lactating.'}, 'identificationModule': {'nctId': 'NCT03602404', 'acronym': 'ITURN', 'briefTitle': 'Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Estimating the Usual Iodine Intake From Spot Urinary Iodine Concentrations to Obtain the Prevalence of Inadequate or Excess Iodine Intake in School-aged Children and Adults', 'orgStudyIdInfo': {'id': 'ITURN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'St. Petersburg: School aged children', 'description': 'Generally healthy 9 to 12 years old children'}, {'label': 'St. Petersburg: Women of reproductive age', 'description': 'Generally healthy non-pregnant, non-lactating women between 18 and 44 years of age'}, {'label': 'Papua New Guinea: School aged children', 'description': 'Generally healthy 9 to 12 years old children'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sia', 'state': 'Morobe Province', 'country': 'Papua New Guinea', 'facility': 'University of Papua New Guinea'}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Almazov Medical Research Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Almazov National Medical Research Centre', 'class': 'OTHER'}, {'name': 'University of Papua New Guinea', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Maria Andersson', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}