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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Selenium 80 mg bid for 90 days
Methimazole starting dose depending on FT3 values (15 mg/day or 20 mg/day or 30 mg/day, for FT3 values \<10 pg/ml, 10-15 pg/ml, \>15 pg/ml, respectively) to be tapered by 5 mg/day every 15 days down to values sufficient for FT3 to be normal
Endocrinology Unit
Pisa, PI, Italy
Control of hyperthyroidism
Comparison of FT3 and FT4 values (pg/ml) between groups
Time frame: 90 days
Clinical manifestations of hyperthyroidism-1
Comparison of heart rate between groups
Time frame: 90 days
Clinical manifestations of hyperthyroidism-2
Comparison of BMI between groups
Time frame: 90 days
Clinical manifestations of hyperthyroidism-3
Comparison of total serum cholesterol between groups
Time frame: 90 days
Clinical manifestations of hyperthyroidism-4
Comparison of total serum sex hormone binding globulin between groups
Time frame: 90 days
Clinical manifestations of hyperthyroidism-5
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Time frame: 90 days
Control of hyperthyroidism
Comparison of FT3 and FT4 values (pg/ml) between groups
Time frame: 45 days
Clinical manifestations of hyperthyroidism-1
Comparison of heart rate between groups
Time frame: 45 days
Selenium levels
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Comparison of serum selenium levels between groups
Time frame: 45 days
Selenium levels
Comparison of serum selenium levels between groups
Time frame: 90 days
Oxidative stress parameters-1
Comparison of serum malondialdehyde levels between groups
Time frame: 45 days
Oxidative stress parameters-2
Comparison of serum glutathione peroxidase levels between groups
Time frame: 45 days
Thyroid autoimmunity-1
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Time frame: 45 days
Thyroid autoimmunity-2
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Time frame: 45 days
Oxidative stress parameters-1
Comparison of serum malondialdehyde levels between groups
Time frame: 90 days
Oxidative stress parameters-2
Comparison of serum glutathione peroxidase levels between groups
Time frame: 90 days
Thyroid autoimmunity-1
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Time frame: 90 days
Thyroid autoimmunity
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Time frame: 90 days
Adverse events of selenium
Time frame: 45 days
Adverse events of selenium
Time frame: 90 days
Clinical manifestatations of hyperthyroidism-2
Comparison of BMI between groups
Time frame: 45 days
Clinical manifestations of hyperthyroidism-3
Comparison of total serum sex hormone binding globulin between groups
Time frame: 45 days
Clinical manifestations of hyperthyroidism-4
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Time frame: 45 days