Selenium Supplementation Versus Placebo in Patients with Graves' Hyperthyroidism
- Conditions
- Graves' Hyperthyroidism
- Interventions
- Dietary Supplement: SeleniumOther: Placebo
- Registration Number
- NCT01611896
- Lead Sponsor
- Rigshospitalet, Denmark
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 431
- Age 18 years or older.
- Active Graves' hyperthyroidism (suppressed TSH (< 0.1) and positive TRAb) measured within the last two months prior to the inclusion date.
- Written informed consent
- Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Selenium Selenium - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of participants with the composite outcome of 'ATD treatment failure' Last 12 months (± 1 month) of the intervention period '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.
- Secondary Outcome Measures
Name Time Method 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) 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 Hyperthyroid symptoms (ThyPRO subscale) during first year after randomisation First year after randomisation Proportion of participants who has thyroid hyperfunction (TSH <0.1) during the last 12 months (± 1 month) of the intervention period Last 12 months (± 1 month) of the intervention period 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 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 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.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)
Trial Locations
- Locations (8)
Department of Endocrinology and Gastroenterology, Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Department of Endocrinology, Hospital of Southwest Denmark
🇩🇰Esbjerg, Denmark
Department of Internal Medicine O 106, Endocrine Unit, Herlev Hospital
🇩🇰Herlev, Denmark
Department of Endocrinology, Section 541, Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Department of Cardiology and Endocrinology, Endocrine Unit, Hillerød Hospital
🇩🇰Hillerød, Denmark
Department of Medicine, Gentofte Hospital
🇩🇰Gentofte, Denmark
Department of Endocrinology and Metabolism, Odense University Hospital
🇩🇰Odense, Denmark
Department of Medical Endocrinology, Rigshospitalet
🇩🇰Copenhagen, Denmark