Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Graves' Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727738
• Other study ID #: UPisa
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: April 4, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Hyperthyroid untreated Graves' disease patients

Exclusion Criteria:

• Hyperthyroid treated Graves' disease patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease
• Hyperthyroidism

Intervention

Dietary Supplement:
• Selenium
Selenium 80 mg bid for 90 days

Drug:
• Methimazole
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

Locations

Country	Name	City	State
Italy	Endocrinology Unit	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of hyperthyroidism	Comparison of FT3 and FT4 values (pg/ml) between groups	90 days	No
Primary	Clinical manifestations of hyperthyroidism-1	Comparison of heart rate between groups	90 days	No
Primary	Clinical manifestations of hyperthyroidism-2	Comparison of BMI between groups	90 days	No
Primary	Clinical manifestations of hyperthyroidism-3	Comparison of total serum cholesterol between groups	90 days	No
Primary	Clinical manifestations of hyperthyroidism-4	Comparison of total serum sex hormone binding globulin between groups	90 days	No
Primary	Clinical manifestations of hyperthyroidism-5	Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups	90 days	No
Secondary	Control of hyperthyroidism	Comparison of FT3 and FT4 values (pg/ml) between groups	45 days	No
Secondary	Clinical manifestations of hyperthyroidism-1	Comparison of heart rate between groups	45 days	No
Secondary	Selenium levels	Comparison of serum selenium levels between groups	45 days	No
Secondary	Selenium levels	Comparison of serum selenium levels between groups	90 days	No
Secondary	Oxidative stress parameters-1	Comparison of serum malondialdehyde levels between groups	45 days	No
Secondary	Oxidative stress parameters-2	Comparison of serum glutathione peroxidase levels between groups	45 days	No
Secondary	Thyroid autoimmunity-1	Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups	45 days	No
Secondary	Thyroid autoimmunity-2	Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups	45 days	No
Secondary	Oxidative stress parameters-1	Comparison of serum malondialdehyde levels between groups	90 days	No
Secondary	Oxidative stress parameters-2	Comparison of serum glutathione peroxidase levels between groups	90 days	No
Secondary	Thyroid autoimmunity-1	Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups	90 days	No
Secondary	Thyroid autoimmunity	Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups	90 days	No
Secondary	Adverse events of selenium		45 days	Yes
Secondary	Adverse events of selenium		90 days	Yes
Secondary	Clinical manifestatations of hyperthyroidism-2	Comparison of BMI between groups	45 days	No
Secondary	Clinical manifestations of hyperthyroidism-3	Comparison of total serum sex hormone binding globulin between groups	45 days	No
Secondary	Clinical manifestations of hyperthyroidism-4	Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups	45 days	No