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
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 t...
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BMC
2023-04-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07282-4 |
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| author | Chae Won Chung Kyong Yeun Jung Eun Hye Jung Min Joung Lee Young Joo Park Jeong Kyu Lee Hwa Young Ahn Sun Wook Cho |
| author_facet | Chae Won Chung Kyong Yeun Jung Eun Hye Jung Min Joung Lee Young Joo Park Jeong Kyu Lee Hwa Young Ahn Sun Wook Cho |
| author_sort | Chae Won Chung |
| collection | DOAJ |
| 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 . |
| first_indexed | 2024-04-09T17:45:00Z |
| format | Article |
| id | doaj.art-62ca52e66601405787c957ea35de8e38 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T17:45:00Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-62ca52e66601405787c957ea35de8e382023-04-16T11:24:22ZengBMCTrials1745-62152023-04-0124111010.1186/s13063-023-07282-4Efficacy 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 trialChae Won Chung0Kyong Yeun Jung1Eun Hye Jung2Min Joung Lee3Young Joo Park4Jeong Kyu Lee5Hwa Young Ahn6Sun Wook Cho7Department of Internal Medicine, College of Medicine, Seoul National UniversityDepartment of Internal Medicine, Nowon Eulji Medical Center, Eulji UniversityDepartment of Ophthalmology, Nowon Eulji Medical Center, Eulji UniversityDepartment of Ophthalmology, Hallym University Sacred Heart HospitalDepartment of Internal Medicine, College of Medicine, Seoul National UniversityDepartment of Ophthalmology, College of Medicine, Chung-Ang UniversityDepartment of Internal Medicine, College of Medicine, Chung-Ang UniversityDepartment of Internal Medicine, College of Medicine, Seoul National UniversityAbstract 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 .https://doi.org/10.1186/s13063-023-07282-4Graves’ ophthalmopathy (GO)SeleniumGraves’ diseaseQuality of life |
| spellingShingle | Chae Won Chung Kyong Yeun Jung Eun Hye Jung Min Joung Lee Young Joo Park Jeong Kyu Lee Hwa Young Ahn Sun Wook Cho 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 Trials Graves’ ophthalmopathy (GO) Selenium Graves’ disease Quality of life |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Graves’ ophthalmopathy (GO) Selenium Graves’ disease Quality of life |
| url | https://doi.org/10.1186/s13063-023-07282-4 |
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