Clinical Trial: Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Pisa

Current Primary Outcome:

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome:

• Control of hyperthyroidism [ Time Frame: 45 days ]
  Comparison of FT3 and FT4 values (pg/ml) between groups
• Clinical manifestations of hyperthyroidism-1 [ Time Frame: 45 days ]
  Comparison of heart rate between groups
• Selenium levels [ Time Frame: 45 days ]
  Comparison of serum selenium levels between groups
• Selenium levels [ Time Frame: 90 days ]
  Comparison of serum selenium levels between groups
• Oxidative stress parameters-1 [ Time Frame: 45 days ]
  Comparison of serum malondialdehyde levels between groups
• Oxidative stress parameters-2 [ Time Frame: 45 days ]
  Comparison of serum glutathione peroxidase levels between groups
• Thyroid autoimmunity-1 [ Time Frame: 45 days ]
  Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
• Thyroid autoimmunity-2 [ Time Frame: 45 days ]
  Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
• Oxidative stress parameters-1 [ Time Frame: 90 days ]
  Comparison of serum malondialdehyde levels between groups
• Oxidative stress parameters-2 [ Time Frame: 90 days ]
  Comparison of serum glutathione peroxidase levels between groups
• Thyroid autoimmunity-1 [ Time Frame: 90 days ]
  Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
• Thyroid autoimmunity [ Time Frame: 90 days ]
  Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
• Adverse events of selenium [ Time Frame: 45 days ]
• Adverse events of selenium [ Time Frame: 90 days ]
• Clinical manifestatations of hyperthyroidism-2 [ Time Frame: 45 days ]
  Comparison of BMI between groups
• Clinical manifestations of hyperthyroidism-3 [ Time Frame: 45 days ]
  Comparison of total serum sex hormone binding globulin between groups
• Clinical manifestations of hyperthyroidism-4 [ Time Frame: 45 days ]
  Comparison of total serum sex hormone binding globulin between groups
• Clinical manifestations of hyperthyroidism-5 [ Time Frame: 45 days ]
  Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups

Information By: University of Pisa

Dates:
Date Received: June 30, 2015
Date Started: January 2014
Date Completion:
Last Updated: April 4, 2016
Last Verified: April 2016