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

Table 2 Schedule of data collection during the follow-up period

	Screening	3 months	6 months
Eligibility screening	X
Informed consent	X
Eye examination
Physical examination	X	X	X
GO-QOL questionnaire	X	X	X
CAS determination	X	X	X
Orbital CT (noncontract)	X
Frontal photography of the eyes	X	X	X
Anthropometric and cardiometabolic assessment
Height	X
Weight	X	X	X
Blood pressure	X	X	X
Pulse rate	X	X	X
Laboratory tests
Selenium	X		X
TSH, free T4 and/or free T3	X	X	X
TBII and anti-TPO Ab	X	X	X
CBC	X		X
AST and ALT	X		X
BUN and creatinine	X		X
Fasting glucose	X		X
Total and LDL cholesterol, triglycerides	X		X
Thyroid ultrasonography	X		X

Abbreviations: GO-QOL Graves’ Ophthalmopathy Quality of Life Questionnaire, CAS clinical activity score, CT computed tomography, TSH thyroid-stimulating hormone, TBII thyrotropin-binding inhibitor immunoglobulin, anti-TPO Ab thyroid peroxidase antibody, CBC complete blood count, AST aspartate aminotransferase ALT alanine aminotransferase, BUN blood urea nitrogen, LDL low-density lipoprotein

ISSN: 1745-6215