431
Participants
Start Date
October 31, 2012
Primary Completion Date
June 30, 2021
Study Completion Date
August 31, 2024
Selenium
100 µg tablets. The dose of daily supplement of selenium is set at 200 µg (two tablets). The duration of the intervention period is between 24-30 months. This is defined by the time of ATD treatment withdrawal, which is scheduled between approximately 12-18 months after randomisation. Selenium supplementation will continue 12 months after withdrawal of ATD treatment.
Placebo
Placebo tablets, identical in regards to size, appearance, taste, smell, and solubility to the experimental intervention tablet will be produced by Jemo-Pharm A/S, http://www.jemo-pharm.dk/frame.cfm/cms/id=977/sprog=2/grp=6/menu=1/ (content as in section: Auxiliary agents). The placebo regimen will be identical to the selenium regimen, but consist of two non-active tablets per day for 24-30 months.
Department of Endocrinology and Gastroenterology, Bispebjerg Hospital, Copenhagen
Department of Medical Endocrinology, Rigshospitalet, Copenhagen
Department of Endocrinology, Hospital of Southwest Denmark, Esbjerg
Department of Medicine, Gentofte Hospital, Gentofte Municipality
Department of Internal Medicine O 106, Endocrine Unit, Herlev Hospital, Herlev
Department of Cardiology and Endocrinology, Endocrine Unit, Hillerød Hospital, Hillerød
Department of Endocrinology, Section 541, Hvidovre Hospital, Hvidovre
Department of Endocrinology and Metabolism, Odense University Hospital, Odense
Odense University Hospital
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Herlev Hospital
OTHER
Bispebjerg Hospital
OTHER
Hvidovre University Hospital
OTHER
Hillerod Hospital, Denmark
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Danish Council for Independent Research
OTHER
The Danish Council for Strategic Research
OTHER
Rigshospitalet, Denmark
OTHER