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Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Primary Purpose

Graves' Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Selenium
Methimazole
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves' Disease focused on measuring Hyperthyroidism, Methimazole, Selenium

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hyperthyroid untreated Graves' disease patients

Exclusion Criteria:

  • Hyperthyroid treated Graves' disease patients

Sites / Locations

  • Endocrinology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methimazole plus selenium

Methimazole

Arm Description

Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days

Methimazole 5-30 mg daily for 90 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2015
Last Updated
April 4, 2016
Sponsor
University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT02727738
Brief Title
Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole
Official Title
Randomized Open Clinical Study to Evaluate the Efficacy of Selenium Plus Methimazole for Treatment of Graves' Hyperthyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves' Disease
Keywords
Hyperthyroidism, Methimazole, Selenium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methimazole plus selenium
Arm Type
Experimental
Arm Description
Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days
Arm Title
Methimazole
Arm Type
Active Comparator
Arm Description
Methimazole 5-30 mg daily for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Selenium
Other Intervention Name(s)
Syrel
Intervention Description
Selenium 80 mg bid for 90 days
Intervention Type
Drug
Intervention Name(s)
Methimazole
Other Intervention Name(s)
Tapazole
Intervention Description
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
Primary Outcome Measure Information:
Title
Control of hyperthyroidism
Description
Comparison of FT3 and FT4 values (pg/ml) between groups
Time Frame
90 days
Title
Clinical manifestations of hyperthyroidism-1
Description
Comparison of heart rate between groups
Time Frame
90 days
Title
Clinical manifestations of hyperthyroidism-2
Description
Comparison of BMI between groups
Time Frame
90 days
Title
Clinical manifestations of hyperthyroidism-3
Description
Comparison of total serum cholesterol between groups
Time Frame
90 days
Title
Clinical manifestations of hyperthyroidism-4
Description
Comparison of total serum sex hormone binding globulin between groups
Time Frame
90 days
Title
Clinical manifestations of hyperthyroidism-5
Description
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Control of hyperthyroidism
Description
Comparison of FT3 and FT4 values (pg/ml) between groups
Time Frame
45 days
Title
Clinical manifestations of hyperthyroidism-1
Description
Comparison of heart rate between groups
Time Frame
45 days
Title
Selenium levels
Description
Comparison of serum selenium levels between groups
Time Frame
45 days
Title
Selenium levels
Description
Comparison of serum selenium levels between groups
Time Frame
90 days
Title
Oxidative stress parameters-1
Description
Comparison of serum malondialdehyde levels between groups
Time Frame
45 days
Title
Oxidative stress parameters-2
Description
Comparison of serum glutathione peroxidase levels between groups
Time Frame
45 days
Title
Thyroid autoimmunity-1
Description
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Time Frame
45 days
Title
Thyroid autoimmunity-2
Description
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Time Frame
45 days
Title
Oxidative stress parameters-1
Description
Comparison of serum malondialdehyde levels between groups
Time Frame
90 days
Title
Oxidative stress parameters-2
Description
Comparison of serum glutathione peroxidase levels between groups
Time Frame
90 days
Title
Thyroid autoimmunity-1
Description
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Time Frame
90 days
Title
Thyroid autoimmunity
Description
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Time Frame
90 days
Title
Adverse events of selenium
Time Frame
45 days
Title
Adverse events of selenium
Time Frame
90 days
Title
Clinical manifestatations of hyperthyroidism-2
Description
Comparison of BMI between groups
Time Frame
45 days
Title
Clinical manifestations of hyperthyroidism-3
Description
Comparison of total serum sex hormone binding globulin between groups
Time Frame
45 days
Title
Clinical manifestations of hyperthyroidism-4
Description
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hyperthyroid untreated Graves' disease patients Exclusion Criteria: Hyperthyroid treated Graves' disease patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Marcocci, MD
Organizational Affiliation
Department of Clinical and Experimental Medicine, University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology Unit
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

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