Clinical trial NCT02727738: 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
Overall status: COMPLETED
Phase: NA
Conditions: Graves' Disease
Keywords: Hyperthyroidism
Methimazole
Selenium
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Hyperthyroid untreated Graves' disease patients

Exclusion Criteria:

* Hyperthyroid treated Graves' disease patients

Primary outcomes:
measure: Control of hyperthyroidism
timeFrame: 90 days
measure: Clinical manifestations of hyperthyroidism-1
timeFrame: 90 days
measure: Clinical manifestations of hyperthyroidism-2
timeFrame: 90 days
measure: Clinical manifestations of hyperthyroidism-3
timeFrame: 90 days
measure: Clinical manifestations of hyperthyroidism-4
timeFrame: 90 days
measure: Clinical manifestations of hyperthyroidism-5
timeFrame: 90 days
Secondary outcomes:
measure: Control of hyperthyroidism
timeFrame: 45 days
measure: Clinical manifestations of hyperthyroidism-1
timeFrame: 45 days
measure: Selenium levels
timeFrame: 45 days
measure: Selenium levels
timeFrame: 90 days
measure: Oxidative stress parameters-1
timeFrame: 45 days
measure: Oxidative stress parameters-2
timeFrame: 45 days
measure: Thyroid autoimmunity-1
timeFrame: 45 days
measure: Thyroid autoimmunity-2
timeFrame: 45 days
measure: Oxidative stress parameters-1
timeFrame: 90 days
measure: Oxidative stress parameters-2
timeFrame: 90 days
measure: Thyroid autoimmunity-1
timeFrame: 90 days
measure: Thyroid autoimmunity
timeFrame: 90 days
measure: Adverse events of selenium
timeFrame: 45 days
measure: Adverse events of selenium
timeFrame: 90 days
measure: Clinical manifestatations of hyperthyroidism-2
timeFrame: 45 days
measure: Clinical manifestations of hyperthyroidism-3
timeFrame: 45 days
measure: Clinical manifestations of hyperthyroidism-4
timeFrame: 45 days
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Endocrinology Unit
state: PI
Study officials:
affiliation: Department of Clinical and Experimental Medicine, University of Pisa
name: Claudio Marcocci, MD
role: PRINCIPAL_INVESTIGATOR
References: