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 trialopen access
- Authors
- Chung, C.W.; Jung, K.Y.; Jung, E.H.; Lee, M.J.; Park, Y.J.; Lee, J.K.; Ahn, H.Y.; Cho, S.W.
- Issue Date
- Apr-2023
- Publisher
- NLM (Medline)
- Keywords
- Graves’ disease; Graves’ ophthalmopathy (GO); Quality of life; Selenium
- Citation
- Trials, v.24, no.1, pp 272
- Journal Title
- Trials
- Volume
- 24
- Number
- 1
- Start Page
- 272
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/68244
- DOI
- 10.1186/s13063-023-07282-4
- ISSN
- 1745-6215
1745-6215
- 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).
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