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

March 30, 2015 updated by: Jan Calissendorff, MD, 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Eskilstuna, Sweden, 63188
        • Emil Mikulski
    • Södermanland
      • Eskilstuna, Södermanland, Sweden, 63188
        • Jan Calissendorff, Medical clinic, Eskilstuna, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on neuropsychological well-being
Time Frame: Inclusion going on until the end of 2011
Inclusion going on until the end of 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Potential effect on autoantibodies
Time Frame: Inclusion for the rest of 2011
Inclusion for the rest of 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Jan Calissendorff, MD, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (ESTIMATE)

November 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLL-159361

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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