Efficacy of selenium supplementation for mild-to-moderate Graves' ophthalmopathy in a selenium-sufficient area (SeGOSS trial): study protocol for a phase III, multicenter, open-label, randomized, controlled intervention trial
DC Field | Value | Language |
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dc.contributor.author | Chung, C.W. | - |
dc.contributor.author | Jung, K.Y. | - |
dc.contributor.author | Jung, E.H. | - |
dc.contributor.author | Lee, M.J. | - |
dc.contributor.author | Park, Y.J. | - |
dc.contributor.author | Lee, J.K. | - |
dc.contributor.author | Ahn, H.Y. | - |
dc.contributor.author | Cho, S.W. | - |
dc.date.accessioned | 2023-10-24T01:41:18Z | - |
dc.date.available | 2023-10-24T01:41:18Z | - |
dc.date.issued | 2023-04 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/68244 | - |
dc.description.abstract | BACKGROUND: The therapeutic effect of selenium has been demonstrated in mild Graves' ophthalmopathy (GO) in a European region where selenium status is suboptimal. However, there is a lack of evidence to support selenium use in selenium-sufficient areas. The aim of this study is to evaluate the therapeutic effect of selenium in mild-to-moderate GO in selenium-sufficient South Korea. METHODS: The SeGOSS trial is a multicenter, prospective, randomized, open-label trial in South Korea. Eighty-four patients aged 19 years or older with mild-to-moderate GO will be randomized to receive either vitamin B complex alone or vitamin B complex with selenium for 6 months with three monthly follow-up visits. The primary outcome is comparison of the improvement in quality of life at 6 months from baseline between the control and selenium groups. The secondary outcomes are intergroup differences in changes in quality of life at 3 months, clinical activity of GO at 3 and 6 months, thyroid autoantibody titers at 3 and 6 months, and the response rate at 3 and 6 months from baseline. Quality of life will be measured by questionnaire for patients with GO, and the clinical activity of GO will be evaluated by the clinical activity score (CAS). A positive response is defined as either changes in the CAS < 0 or the changes in the GO-QOL score ≥ 6. DISCUSSION: The SeGOSS study will evaluate the therapeutic potential of selenium for mild-to-moderate GO in a selenium-sufficient area and provide support in tailoring better treatment for GO. TRIAL REGISTRATION: KCT0004040. Retrospectively registered on 5 June 2019. https://cris.nih.go.kr/cris/search/detailSearch.do/14160 . © 2023. The Author(s). | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | NLM (Medline) | - |
dc.title | Efficacy of selenium supplementation for mild-to-moderate Graves' ophthalmopathy in a selenium-sufficient area (SeGOSS trial): study protocol for a phase III, multicenter, open-label, randomized, controlled intervention trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1186/s13063-023-07282-4 | - |
dc.identifier.bibliographicCitation | Trials, v.24, no.1, pp 272 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.wosid | 000971836900002 | - |
dc.identifier.scopusid | 2-s2.0-85152532381 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 272 | - |
dc.citation.title | Trials | - |
dc.citation.volume | 24 | - |
dc.type.docType | Article | - |
dc.publisher.location | 영국 | - |
dc.subject.keywordAuthor | Graves’ disease | - |
dc.subject.keywordAuthor | Graves’ ophthalmopathy (GO) | - |
dc.subject.keywordAuthor | Quality of life | - |
dc.subject.keywordAuthor | Selenium | - |
dc.subject.keywordPlus | QUALITY-OF-LIFE | - |
dc.subject.keywordPlus | AUTOIMMUNE-THYROIDITIS | - |
dc.subject.keywordPlus | ORBITAL DECOMPRESSION | - |
dc.subject.keywordPlus | EUROPEAN GROUP | - |
dc.subject.keywordPlus | DISEASE | - |
dc.subject.keywordPlus | ORBITOPATHY | - |
dc.subject.keywordPlus | DEFICIENCY | - |
dc.subject.keywordPlus | PROTEIN | - |
dc.subject.keywordPlus | QUESTIONNAIRE | - |
dc.subject.keywordPlus | LYMPHOCYTES | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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