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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jan Calissendorff, MD, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01247077
First received: November 23, 2010
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Quality of Life 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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Effect on neuropsychological well-being [ Time Frame: Inclusion going on until the end of 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Potential effect on autoantibodies [ Time Frame: Inclusion for the rest of 2011 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247077

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

No publications provided

Responsible Party: Jan Calissendorff, MD, Senior consultant, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01247077     History of Changes
Other Study ID Numbers: DLL-159361
Study First Received: November 23, 2010
Last Updated: May 21, 2013
Health Authority: Regional Ethics committé, Stockholm, Sweden':'

Keywords provided by Karolinska Institutet:
selenium
neuropsychological testing
autoantibodies

Additional relevant MeSH terms:
Thyroid Diseases
Thyrotoxicosis
Endocrine System Diseases
Hyperthyroidism
Selenium
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013