Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

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

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.

Study Overview

• Status: Completed
• Conditions: Graves' Disease
• Intervention / Treatment: Dietary supplement: Selenium; Drug: Methimazole

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PI
    • Pisa, PI, Italy, 56124
      • Endocrinology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hyperthyroid untreated Graves' disease patients

Exclusion Criteria:

• Hyperthyroid treated Graves' disease patients

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methimazole plus selenium; Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days	Dietary supplement: Selenium; Selenium 80 mg bid for 90 days; Other Names: Syrel; 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; Other Names: Tapazole
Active Comparator: Methimazole; Methimazole 5-30 mg daily 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; Other Names: Tapazole

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pisa
• Investigators: Principal Investigator: Claudio Marcocci, MD, Department of Clinical and Experimental Medicine, University of Pisa

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Selenium; Hyperthyroidism; Methimazole
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Graves Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Trace Elements; Micronutrients; Hormone Antagonists; Antioxidants; Antithyroid Agents; Selenium; Methimazole
• Other Study ID Numbers: UPisa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No