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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo

Placebo and thyroxin + methimazole

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type OTHER

selenium

selenium + methimazole + thyroxin

Group Type PLACEBO_COMPARATOR

selenium

Intervention Type OTHER

200 ug selenium once daily

Interventions

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selenium

200 ug selenium once daily

Intervention Type OTHER

placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No