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

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ClinicalTrials.gov Identifier: NCT01247077
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Jan Calissendorff, MD, Karolinska Institutet

Brief Summary:
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 or disease Intervention/treatment Phase
QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis Potential Effect of Selenium Other: selenium Other: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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?
Study Start Date : November 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: placebo
Placebo and thyroxin + methimazole
Other: placebo
Placebo Comparator: selenium
selenium + methimazole + thyroxin
Other: selenium
200 ug selenium once daily



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

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


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jan Calissendorff, MD, Senior consultant, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01247077     History of Changes
Other Study ID Numbers: DLL-159361
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

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

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