Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?

Conditions
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QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis, Potential Effect of Selenium

Intervention / Treatment
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* Other: selenium
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New diagnose of autoimmune thyrotoxicosis biochemically proven with increased thyroxin low TSH and elevated TRAb/or positive scintigraphy. Age 18 - 55. Willing to participate - Exclusion Criteria: No previous head trauma, No difficulties with swedish language, No medication which could affective neuropsychological testing, No planned or ongoing pregnancies. Normal intellectual capacity. No severe ophthalmopathy, or other severe disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: placebo<br>Placebo and thyroxin + methimazole | Other: placebo<br> <br> |
| Placebo Comparator: selenium<br>selenium + methimazole + thyroxin | Other: selenium<br>* 200 ug selenium once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on neuropsychological well-being |  | Inclusion going on until the end of 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential effect on autoantibodies |  | Inclusion for the rest of 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selenium, neuropsychological testing, autoantibodies