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

Potential Effect of Selenium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247077
• Other study ID #: DLL-159361
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2010
• Last updated: March 30, 2015
• Start date: November 2008
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regional Ethics committé, Stockholm, Sweden':'
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

Other:
• selenium
200 ug selenium once daily
• placebo

Locations

Country	Name	City	State
Sweden	Emil Mikulski	Eskilstuna
Sweden	Jan Calissendorff, Medical clinic, Eskilstuna, Sweden	Eskilstuna	Södermanland

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on neuropsychological well-being		Inclusion going on until the end of 2011	No
Secondary	Potential effect on autoantibodies		Inclusion for the rest of 2011	No