Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-03-03 @ 1:36 AM
Study NCT ID:
NCT03731312
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability in Iodine Nutrition Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine, Dried blood spot'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-11-05', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated daily urinary iodine excretion', 'timeFrame': '7 days', 'description': 'Estimated urinary iodine excretion (µg/day) will be obtained from urinary iodine concentration (UIC) and urinary creatinine concentration (UCC) measured in two repeat spot urine samples collected within 7 days'}], 'secondaryOutcomes': [{'measure': 'Measured daily iodine excretion', 'timeFrame': '1 day', 'description': 'Measured daily iodine excretion (µg/day) will be obtained from urinary iodine concentration (UIC) and urine volume in a 24 h urine collection'}, {'measure': 'Thyroid function test TSH', 'timeFrame': '1 day', 'description': 'TSH concentration (mU/L) measured in dried blood spots'}, {'measure': 'Thyroid function test total T4', 'timeFrame': '1 day', 'description': 'Total T4 concentration (nmol/L) measured in dried blood spots'}, {'measure': 'Thyroid function test Tg', 'timeFrame': '1 day', 'description': 'Tg concentration (µg/L) measured in dried blood spots'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iodine', 'Urinary iodine concentration'], 'conditions': ['Iodine Deficiency']}, 'referencesModule': {'references': [{'pmid': '37270291', 'type': 'DERIVED', 'citation': 'Arns-Glaser L, Zihlmann R, Gessler S, Verkaik-Kloosterman J, Zandberg L, Assey VD, Rigutto-Farebrother J, Braegger CP, Zimmermann MB, Andersson M. Estimating habitual iodine intake and prevalence of inadequacy from spot urine in cross-sectional studies: a modeling analysis to determine the required sample size. Am J Clin Nutr. 2023 Jun;117(6):1270-1277. doi: 10.1016/j.ajcnut.2023.03.012. Epub 2023 May 4.'}]}, 'descriptionModule': {'briefSummary': 'Iodine status in populations is assessed using urinary iodine concentration (UIC) measured in spot urine samples. The iodine intake is classified as deficient, sufficient, or excessive iodine based on the median UIC (mUIC). However, this approach has limitations, as it does not quantify the prevalence of individuals with habitually deficient or excess iodine intakes. The EAR cut-point method has the potential to quantify prevalence of iodine deficiency and excess. However, little is known about the effects of the inter- and intra-individual variance of UIC.\n\nThe aim of the study is to quantify the intra-individual variability in dietary iodine intake. The overall goal is to estimate the prevalence of iodine deficiency and excess in the study population and propose sample size recommendations for future iodine nutrition population studies. The results will provide evidence guiding international recommendations for iodine nutrition studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy women of reproductive age and residents of Switzerland since at least 12 months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant\n* Non-lactating\n* Non-smoking\n* Residence in Switzerland ≥12 months\n* Generally healthy\n* No family history of goiter\n* No exposure to iodine containing contrast agents during the last 12 months - Informed consent given\n\nExclusion Criteria:\n\n* Participant is not able to understand the study information or procedure, e.g. due to linguistic barriers'}, 'identificationModule': {'nctId': 'NCT03731312', 'acronym': 'VIOLET', 'briefTitle': 'Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability in Iodine Nutrition Studies', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability on Estimated Intake in Iodine Nutrition Studies', 'orgStudyIdInfo': {'id': 'VIOLET'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'We will collect two repeated spot urine samples, a DBS sample and obtain weight in all 600 study participants. In a randomly selected subsample (n=200) a third repeat spot urine sample and one 24 h urine will additionally be collected.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is an observational study and no interventions will be administered.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8092', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Jessica Rigutto-Farebrother, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETH Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}