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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Calissendorff, MD, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01247077
First received: November 23, 2010
Last updated: March 30, 2015
Last verified: March 2015

November 23, 2010
March 30, 2015
November 2008
March 2014   (final data collection date for primary outcome measure)
Effect on neuropsychological well-being [ Time Frame: Inclusion going on until the end of 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01247077 on ClinicalTrials.gov Archive Site
Potential effect on autoantibodies [ Time Frame: Inclusion for the rest of 2011 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
  • QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis
  • Potential Effect of Selenium
  • Other: selenium
    200 ug selenium once daily
  • Other: placebo
  • Active Comparator: placebo
    Placebo and thyroxin + methimazole
    Intervention: Other: placebo
  • Placebo Comparator: selenium
    selenium + methimazole + thyroxin
    Intervention: Other: selenium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01247077
DLL-159361
No
Jan Calissendorff, MD, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Jan Calissendorff, MD, PhD Karolinska Institutet
Karolinska Institutet
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP