Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: QoL Before and After 9 Month of Medical Treatment of Graves´Thyrotoxicosis; Potential Effect of Selenium
Intervention: selenium (Other); placebo (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s): Jan Calissendorff, MD, PhD, Principal Investigator, Affiliation: Karolinska Institutet
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
Clinical Details
Official title: Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research
Primary outcome: Effect on neuropsychological well-being
Secondary outcome: Potential effect on autoantibodies
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Emil Mikulski, Eskilstuna 63188, Sweden
Jan Calissendorff, Medical clinic, Eskilstuna, Sweden, Eskilstuna, Södermanland 63188, Sweden
Additional Information
Starting date: November 2008
Last updated: March 30, 2015
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