Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism
NCT ID: NCT01611896
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
431 participants
INTERVENTIONAL
2012-10-31
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Selenium
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active Graves' hyperthyroidism (suppressed TSH (\< 0.1) and positive TRAb) measured within the last two months prior to the inclusion date.
* Written informed consent
Exclusion Criteria
* Previous treatment with radioactive iodine.
* Current ATD treatment having been received for more than two months.
* Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, cyclophosphamide.
* Allergy towards the components in the selenium and placebo pills.
* Pregnant or breast-feeding women.
* Intake of selenium supplementation above 70 µg per day (70 µg corresponds to the amount in a multivitamin tablet).
* Unable to read and understand Danish.
* Lack of informed consent
18 Years
ALL
No
Sponsors
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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
Responsible Party
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Per Cramon
Principal Investigator
Principal Investigators
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Aase K Rasmussen, DMSc
Role: STUDY_CHAIR
Department of Medical Endocrinology, Rigshospitalet
Torquil Watt, Ph.D.
Role: STUDY_CHAIR
Department of Medical Endocrinology, Rigshospitalet
Laszlo Hegedüs, DMSc
Role: STUDY_CHAIR
Department of Endocrinology and Metabolism, Odense University Hospital
Steen J Bonnema, Ph.D.
Role: STUDY_CHAIR
Department of Endocrinology and Metabolism, Odense University Hospital
Jeppe Gram, Ph.D.
Role: STUDY_CHAIR
Department of Endocrinology, Hospital of Southwest Denmark
Christian Gluud, DMSc
Role: STUDY_CHAIR
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet
Jakob B Bjorner, Ph.D.
Role: STUDY_CHAIR
National Research Centre for the Working Environment, and Institue of Public Health Science, University of Copenhagen
Per Cramon, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Medical Endocrinology, Rigshospitalet
Locations
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Department of Endocrinology and Gastroenterology, Bispebjerg Hospital
Copenhagen, , Denmark
Department of Medical Endocrinology, Rigshospitalet
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
Countries
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References
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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.
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.
Other Identifiers
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GRASS-DP-240
Identifier Type: OTHER
Identifier Source: secondary_id
2007-58-0015, 30-0770
Identifier Type: OTHER
Identifier Source: secondary_id
H-4-2012-026
Identifier Type: OTHER
Identifier Source: secondary_id
H-4-2012-026
Identifier Type: -
Identifier Source: org_study_id
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