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

This study has been completed.
Information provided by (Responsible Party):
Jan Calissendorff, MD, Karolinska Institutet Identifier:
First received: November 23, 2010
Last updated: March 30, 2015
Last verified: March 2015
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

Condition Intervention Phase
QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis Potential Effect of Selenium Other: selenium Other: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?

Resource links provided by NLM:

Further study details as provided by Jan Calissendorff, MD, Karolinska Institutet:

Primary Outcome Measures:
  • Effect on neuropsychological well-being [ Time Frame: Inclusion going on until the end of 2011 ]

Secondary Outcome Measures:
  • Potential effect on autoantibodies [ Time Frame: Inclusion for the rest of 2011 ]

Enrollment: 44
Study Start Date: November 2008
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: placebo
Placebo and thyroxin + methimazole
Other: placebo
Placebo Comparator: selenium
selenium + methimazole + thyroxin
Other: selenium
200 ug selenium once daily

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01247077

Jan Calissendorff, Medical clinic, Eskilstuna, Sweden
Eskilstuna, Södermanland, Sweden, 63188
Emil Mikulski
Eskilstuna, Sweden, 63188
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Jan Calissendorff, MD, PhD Karolinska Institutet
  More Information

Responsible Party: Jan Calissendorff, MD, Senior consultant, Karolinska Institutet Identifier: NCT01247077     History of Changes
Other Study ID Numbers: DLL-159361
Study First Received: November 23, 2010
Last Updated: March 30, 2015

Keywords provided by Jan Calissendorff, MD, Karolinska Institutet:
neuropsychological testing

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances processed this record on September 20, 2017