EUCTR2010-022840-19-DE
Active, not recruiting
Not Applicable
A monocentric, randomized, placebo-controlled double-blind clinical trial to assess the efficacy of Selenium in Morbus Basedow - Selenium in Morbus Basedow
niversitätsmedizin Mainz0 sitesAugust 23, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitätsmedizin Mainz
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Hyperthyroidism, defined as increased fT3 and TSH below 0\.01mIU/L
- •2\. Autoimmune Morbus Basedow: Positive TSH\-R\-Ab
- •3\. Male and female patients of age: 18\-80 years
- •4\. Written informed consent given
- •5\. No mental illness that prevents patients from comprehensive, written informed consent and study participation
- •6\. Compliant patient, regular follow\-up possible
- •7\. For women with child\-bearing potential: Effective method of contraception during the whole trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Pregnancy, breast\-feeding women
- •2\. Previous selenium or iodine intake within 4 weeks prior to study treatment
- •3\. Pretreatment for Morbus Basedow with anti\-thyroid drugs within 4 weeks prior to study treatment
- •4\. Corticosteroids or other immunosuppressive agents because of M. Basedow extra\-thyroid signs or another condition requiring therapy within 4 weeks prior to study treatment
- •5\. Acute or chronic viral hepatitis
- •6\. Relevant, actual malignant disease
- •7\. Recent history of alcoholism or drug abuse
- •8\. Participation in another clinical trial at the same time or \= during the last 4 weeks
- •9\. Allergic reactions or intolerance to previous trial medication exposure
- •10\. Medical conditions which, according to the summary of product characteristics, the drugs are contraindicated for and if administered, cause a serious health risk to the patient
Outcomes
Primary Outcomes
Not specified
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