CompletedNo phase
Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism
Key facts
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Where
- Denmark8 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 431 people enrolled
- Started
- Oct 2012
- Ended
- Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Selenium
- Placebo
- Record updated
- 13 February 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SeleniumExisting treatment, for comparison
- PlaceboPlacebo, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- GRAves Selenium Supplementation Trial (GRASS) - an Investigator-initiated Randomised, Blinded, Multicentre Clinical Trial of Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism
- Publications
- Record updated
- 13 February 2025