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| ID | Type | Description | Link |
|---|---|---|---|
| GRASS-DP-240 | Other Identifier | Copenhagen Trial Unit | |
| 2007-58-0015, 30-0770 | Other Identifier | Danish Data Protection Agency | |
| H-4-2012-026 | Other Identifier | Regional Research Ethical Committee for the Capital Region |
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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| Herlev Hospital | OTHER |
| Bispebjerg Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with the composite outcome of 'ATD treatment failure' | 'ATD treatment failure' is defined as:
| Last 12 months (± 1 month) of the intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who receives ATD treatment (at any level) during the last 12 months (± 1 month) of the intervention period | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aase K Rasmussen, DMSc | Department of Medical Endocrinology, Rigshospitalet | Study Chair |
| Torquil Watt, Ph.D. | Department of Medical Endocrinology, Rigshospitalet | Study Chair |
| Laszlo Hegedüs, DMSc | Department of Endocrinology and Metabolism, Odense University Hospital | Study Chair |
| Steen J Bonnema, Ph.D. | Department of Endocrinology and Metabolism, Odense University Hospital | Study Chair |
| Jeppe Gram, Ph.D. | Department of Endocrinology, Hospital of Southwest Denmark | Study Chair |
| Christian Gluud, DMSc | Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet | Study Chair |
| Jakob B Bjorner, Ph.D. | National Research Centre for the Working Environment, and Institue of Public Health Science, University of Copenhagen | Study Chair |
| Per Cramon, MD | Department of Medical Endocrinology, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology and Gastroenterology, Bispebjerg Hospital | Copenhagen | Denmark | ||||
| Department of Medical Endocrinology, Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41384622 | Derived | Cramon PK, Winther KH, Boesen VB, Larsen CB, Bjorner JB, Nordqvist SF, Forman JL, Juul AB, Bach-Mortensen P, Knudsen N, Nolsoe RL, Vilsboll T, Andries A, Gram J, Nygaard B, Demircan K, Chillon TS, Schomburg L, Hegedus L, Bonnema SJ, Feldt-Rasmussen U, Rasmussen AK, Watt T. Selenium supplementation in individuals with newly diagnosed Graves' hyperthyroidism: a double-blind, multi-centre RCT. Eur Thyroid J. 2026 Jan 6;15(1):ETJ250264. doi: 10.1530/ETJ-25-0264. Print 2026 Jan 1. | |
| 24519964 |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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| 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 |
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| Placebo | Other | 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. |
|
| 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 | 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 | 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) | 18 months, and at the end of the intervention period (24-30 months) |
| Hyperthyroid symptoms (ThyPRO subscale) during first year after randomisation | First year after randomisation |
| Eye symptoms (ThyPRO subscale) during first year after randomisation, and at end of the intervention period (24-30 months) | 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. | 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:
| Intervention period (24-30 months) |
| Copenhagen |
| Denmark |
| Department of Endocrinology, Hospital of Southwest Denmark | Esbjerg | Denmark |
| Department of Medicine, Gentofte Hospital | Gentofte Municipality | Denmark |
| Department of Internal Medicine O 106, Endocrine Unit, Herlev Hospital | Herlev | Denmark |
| Department of Cardiology and Endocrinology, Endocrine Unit, Hillerød Hospital | Hillerød | Denmark |
| Department of Endocrinology, Section 541, Hvidovre Hospital | Hvidovre | Denmark |
| Department of Endocrinology and Metabolism, Odense University Hospital | Odense | Denmark |
| Derived |
| Cramon P, Rasmussen AK, Bonnema SJ, Bjorner JB, Feldt-Rasmussen U, Groenvold M, Hegedus L, Watt T. Development and implementation of PROgmatic: A clinical trial management system for pragmatic multi-centre trials, optimised for electronic data capture and patient-reported outcomes. Clin Trials. 2014 Jun;11(3):344-354. doi: 10.1177/1740774513517778. |
| 23782950 | Derived | Watt T, Cramon P, Bjorner JB, Bonnema SJ, Feldt-Rasmussen U, Gluud C, Gram J, Hansen JL, Hegedus L, Knudsen N, Bach-Mortensen P, Nolsoe R, Nygaard B, Pociot F, Skoog M, Winkel P, Rasmussen AK. Selenium supplementation for patients with Graves' hyperthyroidism (the GRASS trial): study protocol for a randomized controlled trial. Trials. 2013 Apr 30;14:119. doi: 10.1186/1745-6215-14-119. |
| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D007154 | Immune System Diseases |