Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-07 @ 4:12 PM
Study NCT ID:
NCT02312466
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2014-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swiss National Iodine Survey 2015
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1430}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean height of school aged children and women of reproductive age', 'timeFrame': 'Baseline'}, {'measure': 'Mean weight of school aged children and women of reproductive age', 'timeFrame': 'Baseline'}, {'measure': 'Median urinary fluoride', 'timeFrame': 'Baseline', 'description': 'Analyzed in urine samples from school aged children only.'}, {'measure': 'Population mean folate status', 'timeFrame': 'Baseline', 'description': 'Analysis of red blood cell folate and plasma folate in venous blood samples.'}, {'measure': 'Populations mean iron status', 'timeFrame': 'Baseline', 'description': 'Serum analysis: ferritin, transferrin receptor; in women of reproductive age and pregnant women.'}, {'measure': 'Individual inflammatory state', 'timeFrame': 'Baseline', 'description': 'Serum analysis of CRP and AGP, analyzed only in women'}, {'measure': 'Intake of iodine in micro grams per day', 'timeFrame': 'Baseline', 'description': 'iodine intake assessed by food frequency questionnaire, only in women'}, {'measure': '% of households with adequate iodine coverage', 'timeFrame': 'Baseline', 'description': 'Salt samples only collected from children (subgroup)'}], 'primaryOutcomes': [{'measure': 'Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age', 'timeFrame': 'Baseline', 'description': 'analysis of urine samples'}], 'secondaryOutcomes': [{'measure': 'Population mean thyroglobulin', 'timeFrame': 'Baseline', 'description': 'Analysis of venous blood samples. Assessed only in women'}, {'measure': 'Population mean thyroid stimulating hormone', 'timeFrame': 'Baseline', 'description': 'Analysis of venous blood samples. Assessed only in women'}, {'measure': 'Population mean thyroxine', 'timeFrame': 'Baseline', 'description': 'Analysis of venous blood samples. Assessed only in women'}, {'measure': 'Median urinary sodium concentration', 'timeFrame': 'Baseline'}, {'measure': 'Median urinary creatinin concentration', 'timeFrame': 'Baseline'}]}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '30843107', 'type': 'DERIVED', 'citation': 'Andersson M, Hunziker S, Fingerhut R, Zimmermann MB, Herter-Aeberli I. Effectiveness of increased salt iodine concentration on iodine status: trend analysis of cross-sectional national studies in Switzerland. Eur J Nutr. 2020 Mar;59(2):581-593. doi: 10.1007/s00394-019-01927-4. Epub 2019 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the authorities regarding iodine content in iodized salt. As a proxy for the entire population the investigators will study school aged children, pregnant women and women of reproduction age.', 'detailedDescription': 'In a national sample of school aged children (n=990), pregnant women (n=700) and women of reproductive age (n=700) urinary iodine will be determined in order to assess iodine nutrition in Switzerland. In addition, in both groups of women a blood sample will be taken for the determination of thyroid hormones, iron- and folate status. Questionnaires will be used for the determination of dietary iodine and salt intake as well as sociodemographic parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '44 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'school aged children, 6-12 years pregnant women, 18-44 years women of reproductive age, 18-44 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Living in Switzerland for at least 1 year\n* For pregnant women: singleton pregnancy\n\nExclusion Criteria:\n\n* Major known medical illness: thyroid dysfunction, gastrointestinal or metabolic disorders and taking chronic medications\n* For women of reproductive age: pregnancy, breastfeeding\n* Use of X-ray or CT contrast agent or iodine containing medication within the past year'}, 'identificationModule': {'nctId': 'NCT02312466', 'acronym': 'SIS', 'briefTitle': 'Swiss National Iodine Survey 2015', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Swiss National Iodine Survey 2015; A Cross-sectional Study to Assess Iodine Status in School Children, Women of Reproductive Age and Pregnant Women', 'orgStudyIdInfo': {'id': 'SIS 2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'School aged children'}, {'label': 'Pregnant women'}, {'label': 'Women of reproductive age'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8092', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Human Nutrition Laboratory, ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isabelle Herter-Aeberli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal Food Safety and Veterinary Office (Switzerland)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Isabelle Herter-Aeberli', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}