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OpenTrials
Completed

NCT Number: NCT01247077

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

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

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jan Calissendorff, Medical clinic, Eskilstuna, Sweden, Eskilstuna, Södermanland County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selenium

Other

200 ug selenium once daily

Placebo

Other

Primary outcomes

  1. Effect on neuropsychological well-being

    Time frame: Inclusion going on until the end of 2011

Secondary outcomes

  1. Potential effect on autoantibodies

    Time frame: Inclusion for the rest of 2011

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2010
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.