Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT01985204
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2013-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iodine Supplementation in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007455', 'term': 'Iodine'}], 'ancestors': [{'id': 'D006219', 'term': 'Halogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-29', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'T3', 'timeFrame': 'baseline, 3 months and 6 months'}, {'measure': 'T4', 'timeFrame': 'baseline, 3 months and 6 months'}, {'measure': 'total cholesterol', 'timeFrame': 'baseline, 3 months and 6 months'}, {'measure': 'TSH', 'timeFrame': '3 months'}, {'measure': 'leptin', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Change in TSH (thyroid-stimulating hormone)', 'timeFrame': 'change from baseline to 6 months'}, {'measure': 'change in fasting insulin', 'timeFrame': 'change from baseline to 6 months'}, {'measure': 'change in the LDL cholesterol/ HDL cholesterol ratio', 'timeFrame': 'change from baseline to 6 months'}], 'secondaryOutcomes': [{'measure': 'fasting glucose', 'timeFrame': 'baseline, 3 months and 6 months'}, {'measure': 'plasma leptin', 'timeFrame': 'baseline, 3 months and 6 months'}, {'measure': 'LDL cholesterol', 'timeFrame': 'baseline, 3 months and 6 months'}, {'measure': 'HDL cholesterol', 'timeFrame': 'baseline, 3 months and 6 months'}, {'measure': 'Urinary iodine', 'timeFrame': 'change from baseline to 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['iodine', 'thyroid hormones', 'obesity', 'TSH', 'dyslipidemia', 'insulin resistance'], 'conditions': ['Iodine Deficiency', 'Subclinical Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '26203098', 'type': 'DERIVED', 'citation': 'Herter-Aeberli I, Cherkaoui M, El Ansari N, Rohner R, Stinca S, Chabaa L, von Eckardstein A, Aboussad A, Zimmermann MB. Iodine Supplementation Decreases Hypercholesterolemia in Iodine-Deficient, Overweight Women: A Randomized Controlled Trial. J Nutr. 2015 Sep;145(9):2067-75. doi: 10.3945/jn.115.213439. Epub 2015 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.', 'detailedDescription': 'The study will be a double blind, placebo controlled intervention study in obese women living in the Atlas foot mountains in Morocco, an iodine deficient area. Eligible subjects will be randomized into intervention and control group and will receive the respective supplement for 6 months. At baseline, midpoint and endpoint anthropometric as well as metabolic profile will be assessed. A health questionnaire will further be administered monthly when the tablets for the following month are distributed. Urine samples to determine iodine status will also be collected monthly.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of reproductive age (20 to 50 years)\n* Body mass index 27 to 40 kg/m2\n* Having received oral and written information about the aims and procedures of the study\n* Willing to comply with the study procedure\n* Having provided oral and written informed consent\n\nExclusion Criteria:\n\n* Chronic disease or gastrointestinal disorders\n* Nodular goiter\n* Regular use of medication (except oral contraceptives)\n* Pregnancy or lactation\n* Subject who cannot be expected to comply with study protocol'}, 'identificationModule': {'nctId': 'NCT01985204', 'briefTitle': 'Iodine Supplementation in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency', 'orgStudyIdInfo': {'id': 'EK 2013-N-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet', 'interventionNames': ['Dietary Supplement: Placebo tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Iodine tablet', 'interventionNames': ['Dietary Supplement: Iodine tablet']}], 'interventions': [{'name': 'Iodine tablet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Iodine tablets containing 200 ug iodine as potassium iodate', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo tablet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo tablet without iodine', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marrakesh', 'country': 'Morocco', 'facility': 'Universite Caddi Ayad, Faculte de Medecine et de Pharmacie', 'geoPoint': {'lat': 31.63416, 'lon': -7.99994}}, {'city': 'Marrakesh', 'country': 'Morocco', 'facility': 'University Cadi Ayyad, Faculte des Sciences', 'geoPoint': {'lat': 31.63416, 'lon': -7.99994}}], 'overallOfficials': [{'name': 'Isabelle Aeberli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETH Zurich (Switzerland)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Isabelle Aeberli', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}