An interventional study of Selenium and Placebo in Graves' Hyperthyroidism, sponsored by Rigshospitalet, Denmark. Completed at 8 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
Among 10 studies in Graves Disease with a site in Denmark — 2 open to participants now, 3 under way, 1 of them phase 3. Graves Disease · Denmark.
Among the 10 studies in Graves Disease with a site in Denmark, this one is the only one that started in 2012, is one of 3 with no phase, and was the 5th registered.
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's enrollment of 431 is above the median of 60 across 104 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →2 of the 10 studies in Graves Disease with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 39 Graves Disease studies recruiting now, 17 (44%) set no upper age limit and 20 (51%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2012.
Median enrollment 105 across the 8 interventional studies, 253 across the 2 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
1 of 10 have an industry lead sponsor. The 7 most frequent:
Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Rigshospitalet, Denmark has 2 studies filed under Graves Disease — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Graves Disease with a site in Denmark, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Selenium
Other: Placebo
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.
Also known as: 'Selen, organisk selen', produced by Jemo-Pharm A/S
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.
Proportion of participants with the composite outcome of 'ATD treatment failure'
'ATD treatment failure' is defined as: * The participant receives ATD treatment (at any level) during the last 12 months (± 1 month) of the intervention period; or * The participant has thyroid hyperfunction (TSH \<0.1) during the last 12 months (± 1 month) of the intervention period; or * The participant has been referred to ablative therapy (radioactive iodine or thyroid surgery) at some point during the entire intervention period.
Time frame: Last 12 months (± 1 month) of the intervention period
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
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.
Time frame: Intervention period (24-30 months)
Number of participants with serious adverse events during the intervention period
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.
Time frame: Intervention period (24-30 months)
Ran from Oct 2012 to primary completion in Jun 2021, 104 months.
Of 22 interventional studies with no phase under Graves Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 88. This study's 104 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Selenium