Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

NCT ID: NCT02727738

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Graves' Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methimazole plus selenium

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

Group Type: EXPERIMENTAL

Selenium

Intervention Type: DIETARY_SUPPLEMENT

Selenium 80 mg bid for 90 days

Methimazole

Intervention Type: DRUG

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

Methimazole

Methimazole 5-30 mg daily for 90 days

Group Type: ACTIVE_COMPARATOR

Methimazole

Intervention Type: DRUG

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

Interventions

Selenium

Selenium 80 mg bid for 90 days

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

Other Intervention Names

Syrel; Tapazole

Eligibility Criteria

Inclusion Criteria

• Hyperthyroid untreated Graves' disease patients

Exclusion Criteria

• Hyperthyroid treated Graves' disease patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Marinò Michele

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Marcocci, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical and Experimental Medicine, University of Pisa

Locations

Endocrinology Unit

Pisa, PI, Italy

Countries

Italy

Other Identifiers

UPisa

Identifier Type: -

Identifier Source: org_study_id