ClinicalTrials.Veeva

Menu

Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

U

University of Pisa

Status

Completed

Conditions

Graves' Disease

Treatments

Drug: Methimazole
Dietary Supplement: Selenium

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hyperthyroid untreated Graves' disease patients

Exclusion criteria

  • Hyperthyroid treated Graves' disease patients

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Methimazole plus selenium
Experimental group
Description:
Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days
Treatment:
Dietary Supplement: Selenium
Drug: Methimazole
Methimazole
Active Comparator group
Description:
Methimazole 5-30 mg daily for 90 days
Treatment:
Drug: Methimazole

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems