A monocentric, randomized, placebo-controlled double-blind clinical trial to assess the efficacy of Selenium in Morbus Basedow - Selenium in Morbus Basedow

niversitätsmedizin Mainz0 个研究点开始时间: 2011年8月23日最近更新: 2015年10月26日

试验速览

暂无简介。

•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
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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

发起方

niversitätsmedizin Mainz