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

Primary Purpose

QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis, Potential Effect of Selenium

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
selenium
placebo
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis focused on measuring selenium, neuropsychological testing, autoantibodies

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

placebo

selenium

Arm Description

Placebo and thyroxin + methimazole

selenium + methimazole + thyroxin

Outcomes

Primary Outcome Measures

Effect on neuropsychological well-being

Secondary Outcome Measures

Potential effect on autoantibodies

Full Information

First Posted
November 23, 2010
Last Updated
March 30, 2015
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01247077
Brief Title
Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
Official Title
Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis, Potential Effect of Selenium
Keywords
selenium, neuropsychological testing, autoantibodies

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Active Comparator
Arm Description
Placebo and thyroxin + methimazole
Arm Title
selenium
Arm Type
Placebo Comparator
Arm Description
selenium + methimazole + thyroxin
Intervention Type
Other
Intervention Name(s)
selenium
Intervention Description
200 ug selenium once daily
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Effect on neuropsychological well-being
Time Frame
Inclusion going on until the end of 2011
Secondary Outcome Measure Information:
Title
Potential effect on autoantibodies
Time Frame
Inclusion for the rest of 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Calissendorff, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jan Calissendorff, Medical clinic, Eskilstuna, Sweden
City
Eskilstuna
State/Province
Södermanland
ZIP/Postal Code
63188
Country
Sweden
Facility Name
Emil Mikulski
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden

12. IPD Sharing Statement

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

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