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

Karolinska Institute

Status and phase: Completed; Phase 2

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

Treatments: Other: selenium; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01247077

DLL-159361

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

placebo

Active Comparator group

Description:

Placebo and thyroxin + methimazole

Treatment:

Other: placebo

selenium

Placebo Comparator group

Description:

selenium + methimazole + thyroxin

Treatment:

Other: selenium