Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism

Summary

The purpose of this study is to investigate if selenium supplementation to the standard treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a fewer people with anti-thyroid treatment failure and faster remission, in terms of better quality of life during the first year of treatment and more patients staying in remission.

Conditions

• Graves' Hyperthyroidism

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Danish Council for Independent Research

  collaborator OTHER

• The Danish Council for Strategic Research

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Aase K Rasmussen, DMSc · Department of Medical Endocrinology, Rigshospitalet

• Torquil Watt, Ph.D. · Department of Medical Endocrinology, Rigshospitalet

• Laszlo Hegedüs, DMSc · Department of Endocrinology and Metabolism, Odense University Hospital

• Steen J Bonnema, Ph.D. · Department of Endocrinology and Metabolism, Odense University Hospital

• Jeppe Gram, Ph.D. · Department of Endocrinology, Hospital of Southwest Denmark

• Christian Gluud, DMSc · Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet

• Jakob B Bjorner, Ph.D. · National Research Centre for the Working Environment, and Institue of Public Health Science, University of Copenhagen

• Per Cramon, MD · Department of Medical Endocrinology, Rigshospitalet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2021-06-30

Completion

2024-08-31

Countries

• Denmark

Study Locations