Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole
- Conditions
- Graves' Disease
- Interventions
- Dietary Supplement: Selenium
- Registration Number
- NCT02727738
- Lead Sponsor
- University of Pisa
- Brief Summary
Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD) untreated patients.
- Detailed Description
30 untreated GD hyperthyroid patients will be randomized into two groups (A and B). Group A patients will be treated with an anti-thyroid drug (methimazole) at the dose aimed to control hyperthyroidism. Group B patients will be treated with methimazole plus selenium (160 mg daily). Patients will be evaluated at time 0, 45 and 90 days for symptoms of hyperthyroidism (by a specific questionnaire), clinical status (weight, heart rate), laboratory (thyroid function tests, TSHR autoantibodies, serum selenium, index of oxidative stress-MDA, cholesterol, SHBG) and EKG. The aim of the study is to evaluate if the combined treatment (methimazole plus selenium) is more effective than methimazole alone in controlling GD hyperthyroidism.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Hyperthyroid untreated Graves' disease patients
- Hyperthyroid treated Graves' disease patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methimazole plus selenium Selenium Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days Methimazole plus selenium Methimazole Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days Methimazole Methimazole Methimazole 5-30 mg daily for 90 days
- Primary Outcome Measures
Name Time Method Clinical manifestations of hyperthyroidism-4 90 days Comparison of total serum sex hormone binding globulin between groups
Clinical manifestations of hyperthyroidism-3 90 days Comparison of total serum cholesterol between groups
Clinical manifestations of hyperthyroidism-1 90 days Comparison of heart rate between groups
Clinical manifestations of hyperthyroidism-5 90 days Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Control of hyperthyroidism 90 days Comparison of FT3 and FT4 values (pg/ml) between groups
Clinical manifestations of hyperthyroidism-2 90 days Comparison of BMI between groups
- Secondary Outcome Measures
Name Time Method Thyroid autoimmunity 90 days Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Clinical manifestations of hyperthyroidism-1 45 days Comparison of heart rate between groups
Oxidative stress parameters-1 90 days Comparison of serum malondialdehyde levels between groups
Oxidative stress parameters-2 90 days Comparison of serum glutathione peroxidase levels between groups
Thyroid autoimmunity-1 90 days Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Adverse events of selenium 90 days Control of hyperthyroidism 45 days Comparison of FT3 and FT4 values (pg/ml) between groups
Selenium levels 90 days Comparison of serum selenium levels between groups
Clinical manifestations of hyperthyroidism-4 45 days Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Thyroid autoimmunity-2 45 days Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Clinical manifestatations of hyperthyroidism-2 45 days Comparison of BMI between groups
Clinical manifestations of hyperthyroidism-3 45 days Comparison of total serum sex hormone binding globulin between groups
Trial Locations
- Locations (1)
Endocrinology Unit
🇮🇹Pisa, PI, Italy