Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT03761602
Status:
UNKNOWN
Last Update Posted:
2018-12-03
First Post:
2018-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}, 'targetDuration': '8 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-29', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'risk of thyroid disease', 'timeFrame': 'From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months', 'description': 'prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)'}, {'measure': 'pregnancy outcomes', 'timeFrame': 'From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months', 'description': 'prevalence of premature birth, stillbirth and abortion'}], 'secondaryOutcomes': [{'measure': 'prevalence of other pregnant complications', 'timeFrame': 'From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months', 'description': 'prevalence of gestational diabetes mellitus, gestational hypertension, dyslipidemia, etc.'}, {'measure': 'prevalence of thyroid disease in neonates', 'timeFrame': 'From date of birth to 4 weeks after birth', 'description': 'prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies，or findings of thyroid nodules) in neonates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iodine Excess in Pregnancy', 'Selenium Excess in Pregnancy', 'Iodine Deficiency in Pregnancy', 'Selenium Deficiency in Pregnancy']}, 'descriptionModule': {'briefSummary': 'Two hundred and ninety pregnant women with gestational age less than 20 weeks will be recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be monitored until termination of pregnancy, with pregnancy outcomes recorded.', 'detailedDescription': 'The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and selenium condition will be evaluated through dietary recall (on base of Chinese food ingredient information) and biochemical examinations (serum iodine concentrations, urinary iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine and selenium will be monitored and followed up for all the included subjects throughout the pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be collected. And all the complications (especially thyroid disease) in pregnancy will also be recorded. All pregnant women will be followed up until the termination of pregnancy, with pregnancy outcomes recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two hundred and ninety pregnant women with gestational age less than 20 weeks should be recruited in this study and will be followed up throughout the whole pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical confirmation of being pregnant.\n* Being within less than 20 weeks of gestationa.\n\nExclusion Criteria:\n\n* Being pregnant but over 20 weeks of gestationa.\n* Mentally or psychologically unstable.'}, 'identificationModule': {'nctId': 'NCT03761602', 'briefTitle': 'The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease: a Prospective Registry Study', 'orgStudyIdInfo': {'id': 'ISCMS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Proper selenium and iodine condition', 'description': 'The subjects should have proper dietary intake of selenium and iodine, according to Chinese Dietary Reference Intakes (DRIs) (intake of selenium 65μg/d and iodine 230 μg/d).\n\nThe Serum iodine concentration are 45-92μg/L，and the urinary I/Cr 150-249μg/g Cr.\n\nThe Serum selenium concentrations are 18-40μg/L.', 'interventionNames': ['Other: Not applicable (for observational studies)']}, {'label': 'Excessive selenium or iodine condition', 'description': 'The subjects have excessive dietary intake of selenium and iodine, usually more than 2 times of DRIs. The Serum iodine concentration are more than 100μg/L，and the urinary I/Cr more than 300μg/g Cr.\n\nThe Serum selenium concentrations are more than 40μg/L.', 'interventionNames': ['Other: Not applicable (for observational studies)']}, {'label': 'Insufficient selenium or iodine condition', 'description': 'The subjects have insufficient dietary intake of either selenium or iodine, compared with DRIs. The Serum iodine concentration are less than 45μg/L，and the urinary I/Cr less than150μg/g Cr.\n\nThe Serum selenium concentrations are less than 18μg/L.', 'interventionNames': ['Other: Not applicable (for observational studies)']}], 'interventions': [{'name': 'Not applicable (for observational studies)', 'type': 'OTHER', 'description': 'This study is an observational study. No intervention will be administered for research purposes.', 'armGroupLabels': ['Excessive selenium or iodine condition', 'Insufficient selenium or iodine condition', 'Proper selenium and iodine condition']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rongrong Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nutrition physician', 'investigatorFullName': 'Rongrong Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}