A Phase 2 interventional study of selenium and placebo in QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis and Potential Effect of Selenium, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-03-31.
Sponsored by Karolinska Institutet · Phase 2, Interventional, and Health services research
Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this
In the County of Södermanland we include 44 patients with Graves´thyrotoxicosis. They are treated with methimazole and thyroxin, and randomised to selenium or placebo. Neuropsychological investigation is performed, before medical treatment is commenced and repeated after 9 month. Serum concentration of thyroid hormon levels, autoantibodies and selenium are followed.
967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 544 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
Placebo and thyroxin + methimazole
Other: placebo
selenium + methimazole + thyroxin
Other: selenium
200 ug selenium once daily
Effect on neuropsychological well-being
Time frame: Inclusion going on until the end of 2011
Potential effect on autoantibodies
Time frame: Inclusion for the rest of 2011
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet