Clinical Trial: Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: GRAves Selenium Supplementation Trial (GRASS) - an Investigator-initiated Randomised, Blinded, Multicentre Clinical Trial of Selenium Supplementation Versus Placebo in Patients With Graves'

Brief 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.

Detailed Summary:
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: Proportion of participants with the composite outcome of 'ATD treatment failure' [ Time Frame: Last 12 months (± 1 month) of the intervention period ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Proportion of participants who receives ATD treatment (at any level) during the last 12 months (± 1 month) of the intervention period [ Time Frame: Last 12 months (± 1 month) of the intervention period ]
• Proportion of participants who has thyroid hyperfunction (TSH <0.1) during the last 12 months (± 1 month) of the intervention period [ Time Frame: Last 12 months (± 1 month) of the intervention period ]
• Proportion of participants who has been referred to ablative therapy (radioactive iodine or thyroid surgery) at some point during the entire intervention period [ Time Frame: Intervention period (24-30 months) ]
• Thyroid-specific QoL during the first year after randomisation, and at the end of the intervention period (24-30 months), as measured by the global score in the ThyPRO questionnaire [ Time Frame: First year after randomisation, and at the end of the intervention period (24-30 months) ]
• Level of TRAb at 18 months, and at the end of the intervention period (24-30 months) [ Time Frame: 18 months, and at the end of the intervention period (24-30 months) ]
• Hyperthyroid symptoms (ThyPRO subscale) during first year after randomisation [ Time Frame: First year after randomisation ]
• Eye symptoms (ThyPRO subscale) during first year after randomisation, and at end of the intervention period (24-30 months) [ Time Frame: First year after randomisation, and at end of the intervention period (24-30 months) ]
• Number of participants with adverse reactions during the intervention period [ Time Frame: Intervention period (24-30 months) ]
  Participants will be asked to report about known adverse reactions (specified in the protocol) at 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, and 12 months after ATD treatment withdrawal. In addition, participants are instructed to contact their trial contact person in case they experience adverse reactions.
• Number of participants with serious adverse events during the intervention period [ Time Frame: Intervention period (24-30 months) ]

  To make sure we get information on serious adverse events, data on hospital admissions and mortality will be obtained through the national databases (the National Patient Registry and the Danish Civil Registration System) at the end of the trial. Also, participants are informed and instructed to contact their trial contact person in case they:

  • are admitted to a hospital for selenium intoxication;
  • experience a clinical picture indicative of selenium intoxication; or
  • experience a clinical picture unexpected, but suspected to be related to selenium intoxication.

Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: May 29, 2012
Date Started: October 2012
Date Completion: June 2018
Last Updated: October 27, 2015
Last Verified: October 2015