Graves' Disease
Conditions
Keywords
Hyperthyroidism, Methimazole, Selenium
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.
Interventions
DIETARY_SUPPLEMENTSelenium
Selenium 80 mg bid for 90 days
DRUGMethimazole
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
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Hyperthyroid untreated Graves' disease patients
Exclusion criteria
* Hyperthyroid treated Graves' disease patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Control of hyperthyroidism | 90 days | Comparison of FT3 and FT4 values (pg/ml) between groups |
| Clinical manifestations of hyperthyroidism-1 | 90 days | Comparison of heart rate between groups |
| Clinical manifestations of hyperthyroidism-2 | 90 days | Comparison of BMI between groups |
| Clinical manifestations of hyperthyroidism-3 | 90 days | Comparison of total serum cholesterol between groups |
| Clinical manifestations of hyperthyroidism-4 | 90 days | Comparison of total serum sex hormone binding globulin between groups |
| Clinical manifestations of hyperthyroidism-5 | 90 days | Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control of hyperthyroidism | 45 days | Comparison of FT3 and FT4 values (pg/ml) between groups |
| Clinical manifestations of hyperthyroidism-1 | 45 days | Comparison of heart rate between groups |
| Selenium levels | 45 days | Comparison of serum selenium levels between groups |
| Oxidative stress parameters-1 | 45 days | Comparison of serum malondialdehyde levels between groups |
| Oxidative stress parameters-2 | 45 days | Comparison of serum glutathione peroxidase levels between groups |
| Thyroid autoimmunity-1 | 45 days | Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups |
| Thyroid autoimmunity-2 | 45 days | Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups |
| Thyroid autoimmunity | 90 days | Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups |
| Adverse events of selenium | 45 days | — |
| 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 |
| Clinical manifestations of hyperthyroidism-4 | 45 days | Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups |
Countries
Italy
Outcome results
None listed