Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-03 @ 9:10 AM
Study NCT ID:
NCT00379535
Status:
TERMINATED
Last Update Posted:
2011-10-12
First Post:
2006-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Lack of Iodine During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011193', 'term': 'Potassium Iodide'}], 'ancestors': [{'id': 'D007454', 'term': 'Iodides'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017680', 'term': 'Potassium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 374}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2006-09-21', 'studyFirstSubmitQcDate': '2006-09-21', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Prevalence of hypothyroxinemia and hypothyroidism during pregnancy', 'timeFrame': '9 months max'}, {'measure': 'Change in the functional thyroid parameters of mother during iodine treatment', 'timeFrame': '2 years'}, {'measure': 'Comparison of the psychometric development of children , for woman with and without treatment', 'timeFrame': '6, 12, and 24 months'}, {'measure': 'Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy , lack of iodine', 'lack of iodine during pregnancy'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '9349578', 'type': 'BACKGROUND', 'citation': 'Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Ressigeac P, Vertongen F, Grange V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54. doi: 10.1089/thy.1997.7.749.'}, {'type': 'BACKGROUND', 'citation': 'Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.', 'detailedDescription': '374 patients with pregnancy less 12 weeks amenorrhea\n\nPatients randomized in 2 parallel groups (each group with 187 patients)\n\n* one group with 200 µg of potassium iodide\n* one group with placebo\n\nFollow up during 3 years with :\n\n* a selection visit, an inclusion with randomization before 12 weeks amenorrhea\n* and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and 6, 12, and 24 months " post partum "'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy, unique or twiny\n* Patients who agree to take part in the study and able to sign an Informed Consent Form\n\nExclusion Criteria:\n\n* Patients receiving a treatment for thyroid affection, or with thyroid pathology\n* Patients with a chronic pathology like insulin dependent diabetes or arterial hypertension\n* Patients with a treatment supplying iodine or having had a gynecologic exam with a iodine solution in the last 30 days\n* Patients taking part in another clinical test or in the last 30 days\n* Patients with depressive antecedent before pregnancy or taking antidepressant treatment\n* Psychiatric troubles that may interfere with the clinical evaluation\n* Patients under special supervision or trusteeship\n* No social security cover'}, 'identificationModule': {'nctId': 'NCT00379535', 'briefTitle': 'Preventing Lack of Iodine During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years', 'orgStudyIdInfo': {'id': '0501101'}, 'secondaryIdInfos': [{'id': 'PHRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Daily dose of 200 µg of potassium iodide', 'interventionNames': ['Drug: potassium iodide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Daily dose of placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'potassium iodide', 'type': 'DRUG', 'otherNames': ['Iodence'], 'description': 'per os', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'per os', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Endocrinology - University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'CARON PHILIPPE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'WEMEAU Jean-Louis, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHRU LILLE'}, {'name': 'NICCOLI-SIRE Patricia, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU Timone MARSEILLE'}, {'name': 'BRUCKER-DAVIS Francoise, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU NICE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}