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

Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis; Potential Effect of Selenium

Intervention: selenium (Other); placebo (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Karolinska Institutet

Official(s) and/or principal investigator(s):
Jan Calissendorff, MD, PhD, Principal Investigator, Affiliation: Karolinska Institutet


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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Primary outcome: Effect on neuropsychological well-being

Secondary outcome: Potential effect on autoantibodies

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Locations and Contacts

Emil Mikulski, Eskilstuna 63188, Sweden

Jan Calissendorff, Medical clinic, Eskilstuna, Sweden, Eskilstuna, Södermanland 63188, Sweden

Additional Information

Starting date: November 2008
Last updated: March 30, 2015

Page last updated: August 23, 2015

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