Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Open Clinical Study to Evaluate the Efficacy of Selenium Plus Methimazole for Treatment of Graves' Hyperthyroidism

Conditions
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Graves' Disease

Intervention / Treatment
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* Dietary Supplement: Selenium
* Drug: Methimazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hyperthyroid untreated Graves' disease patients Exclusion Criteria: Hyperthyroid treated Graves' disease patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methimazole plus selenium<br>Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days | Dietary Supplement: Selenium<br>* Selenium 80 mg bid for 90 days<br>* Other names: Syrel;Drug: Methimazole<br>* 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<br>* Other names: Tapazole;|
| Active Comparator: Methimazole<br>Methimazole 5-30 mg daily for 90 days | Drug: Methimazole<br>* 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<br>* Other names: Tapazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of hyperthyroidism | Comparison of FT3 and FT4 values (pg/ml) between groups | 90 days | 
| Clinical manifestations of hyperthyroidism-1 | Comparison of heart rate between groups | 90 days | 
| Clinical manifestations of hyperthyroidism-2 | Comparison of BMI between groups | 90 days | 
| Clinical manifestations of hyperthyroidism-3 | Comparison of total serum cholesterol between groups | 90 days | 
| Clinical manifestations of hyperthyroidism-4 | Comparison of total serum sex hormone binding globulin between groups | 90 days | 
| Clinical manifestations of hyperthyroidism-5 | Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of hyperthyroidism | Comparison of FT3 and FT4 values (pg/ml) between groups | 45 days | 
| Clinical manifestations of hyperthyroidism-1 | Comparison of heart rate between groups | 45 days | 
| Selenium levels | Comparison of serum selenium levels between groups | 45 days | 
| Selenium levels | Comparison of serum selenium levels between groups | 90 days | 
| Oxidative stress parameters-1 | Comparison of serum malondialdehyde levels between groups | 45 days | 
| Oxidative stress parameters-2 | Comparison of serum glutathione peroxidase levels between groups | 45 days | 
| Thyroid autoimmunity-1 | Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups | 45 days | 
| Thyroid autoimmunity-2 | Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups | 45 days | 
| Oxidative stress parameters-1 | Comparison of serum malondialdehyde levels between groups | 90 days | 
| Oxidative stress parameters-2 | Comparison of serum glutathione peroxidase levels between groups | 90 days | 
| Thyroid autoimmunity-1 | Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups | 90 days | 
| Thyroid autoimmunity | Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups | 90 days | 
| Adverse events of selenium |  | 45 days | 
| Adverse events of selenium |  | 90 days | 
| Clinical manifestatations of hyperthyroidism-2 | Comparison of BMI between groups | 45 days | 
| Clinical manifestations of hyperthyroidism-3 | Comparison of total serum sex hormone binding globulin between groups | 45 days | 
| Clinical manifestations of hyperthyroidism-4 | Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperthyroidism, Methimazole, Selenium