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

Autor: Chae Won Chung, Kyong Yeun Jung, Eun Hye Jung, Min Joung Lee, Young Joo Park, Jeong Kyu Lee, Hwa Young Ahn, Sun Wook Cho
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Trials, Vol 24, Iss 1, Pp 1-10 (2023)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-023-07282-4
Popis: 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
Databáze: Directory of Open Access Journals
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