Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02302768
Status:
UNKNOWN
Last Update Posted:
2014-11-27
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050031', 'term': 'Hashimoto Disease'}], 'ancestors': [{'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012645', 'term': 'Selenomethionine'}], 'ancestors': [{'id': 'D016566', 'term': 'Organoselenium Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008715', 'term': 'Methionine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-26', 'studyFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of anti-thyroid antibodies', 'timeFrame': '12 months', 'description': 'Anti thyroperoxidase and thyroglobulin antibodies are measured by a chemiluminescent assay. Any statistically significant decrease of one or both antibody values compared to the baseline is considered a reduction relevant to the study outcome.'}, {'measure': 'Improvement of thyroid echogenicity', 'timeFrame': '12 months', 'description': 'High-resolution sonograhic images are captured, converted into a spectrum of gray-scale pixels (gsp) ranging from 0 (lowest echogenicity) to 255 (highest echogenicity) and a mean value is then obtained. Any statistically significant increase of the gsp compared to the baseline is considered an improvement relevant to the study outcome.'}], 'secondaryOutcomes': [{'measure': 'Prevention or reduction of the incidence of hypothyroidism', 'timeFrame': '24 months', 'description': 'Defined by a significant lower number of new subclinical or overt hypothyroidism cases in the two Semet groups compared to the placebo group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thyroiditis Autoimmune']}, 'referencesModule': {'references': [{'pmid': '22381456', 'type': 'BACKGROUND', 'citation': 'Rayman MP. Selenium and human health. Lancet. 2012 Mar 31;379(9822):1256-68. doi: 10.1016/S0140-6736(11)61452-9. Epub 2012 Feb 29.'}, {'pmid': '24419054', 'type': 'BACKGROUND', 'citation': 'Nacamulli D, Petricca D, Mian C. Selenium and autoimmune thyroiditis. J Endocrinol Invest. 2013 Nov;36(10 Suppl):8-14.'}, {'pmid': '21864266', 'type': 'BACKGROUND', 'citation': 'Rotondi M, Chiovato L. The chemokine system as a therapeutic target in autoimmune thyroid diseases: a focus on the interferon-gamma inducible chemokines and their receptor. Curr Pharm Des. 2011;17(29):3202-16. doi: 10.2174/138161211798157559.'}]}, 'descriptionModule': {'briefSummary': 'Over the past 10 years, several clinical studies have suggested that selenium supplementation may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of this prospective, randomized, controlled study is to evaluate the effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity, over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of AIT patients are also evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic autoimmune thyroiditis defined by positivity of anti thyroperoxidase and/or anti thyroglobulin antibodies (\\> or = 100 U/l) and thyroid hypoechogenicity\n\nExclusion Criteria:\n\n* Presence of other thyroid disease but micronodules\n* History of the malignancy in the past 5 years\n* Drugs affecting immune system and/or thyroid function\n* Pregnancy detected during screening or follow-up.'}, 'identificationModule': {'nctId': 'NCT02302768', 'briefTitle': 'Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Effect of Supplementation of Two Doses of L-selenomethionine (Semet; 80 and 160 mcg) Versus Placebo in Patients With Chronic Autoimmune Thyroiditis (AIT) With Normal Thyroid Function.', 'orgStudyIdInfo': {'id': 'SELENIO 2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients randomized to receive same pharmaceutical form (capsule) used for the two Semet groups, with the same excipients but the active drug.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '80-Semet', 'description': 'Patients randomized to receive selenomethionine at 80 mcg per day.', 'interventionNames': ['Dietary Supplement: Selenomethionine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '160-Semet', 'description': 'Patients randomized to receive selenomethionine at 160 mcg per day.', 'interventionNames': ['Dietary Supplement: Selenomethionine']}], 'interventions': [{'name': 'Selenomethionine', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['160-Semet', '80-Semet']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Furio Pacini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Siena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'collaborators': [{'name': 'IBSA Institut Biochimique SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Furio Pacini', 'investigatorAffiliation': 'University of Siena'}}}}