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NCT Number: NCT02727738

Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

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.

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Key information

Conditions

Graves' Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinology Unit

Pisa, PI, 56124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hyperthyroid untreated Graves' disease patients

Exclusion criteria

  • Hyperthyroid treated Graves' disease patients

Treatment and study plan

Selenium

Dietary Supplement

Selenium 80 mg bid for 90 days

Other names: Syrel

methimazole

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

Other names: Tapazole

Primary outcomes

  1. Control of hyperthyroidism

    Time frame: 90 days

    Comparison of FT3 and FT4 values (pg/ml) between groups

  2. Clinical manifestations of hyperthyroidism-1

    Time frame: 90 days

    Comparison of heart rate between groups

  3. Clinical manifestations of hyperthyroidism-2

    Time frame: 90 days

    Comparison of BMI between groups

  4. Clinical manifestations of hyperthyroidism-3

    Time frame: 90 days

    Comparison of total serum cholesterol between groups

  5. Clinical manifestations of hyperthyroidism-4

    Time frame: 90 days

    Comparison of total serum sex hormone binding globulin between groups

  6. Clinical manifestations of hyperthyroidism-5

    Time frame: 90 days

    Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups

Secondary outcomes

  1. Control of hyperthyroidism

    Time frame: 45 days

    Comparison of FT3 and FT4 values (pg/ml) between groups

  2. Clinical manifestations of hyperthyroidism-1

    Time frame: 45 days

    Comparison of heart rate between groups

  3. Selenium levels

    Time frame: 45 days

    Comparison of serum selenium levels between groups

  4. Selenium levels

    Time frame: 90 days

    Comparison of serum selenium levels between groups

  5. Oxidative stress parameters-1

    Time frame: 45 days

    Comparison of serum malondialdehyde levels between groups

  6. Oxidative stress parameters-2

    Time frame: 45 days

    Comparison of serum glutathione peroxidase levels between groups

  7. Thyroid autoimmunity-1

    Time frame: 45 days

    Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups

  8. Thyroid autoimmunity-2

    Time frame: 45 days

    Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups

  9. Oxidative stress parameters-1

    Time frame: 90 days

    Comparison of serum malondialdehyde levels between groups

  10. Oxidative stress parameters-2

    Time frame: 90 days

    Comparison of serum glutathione peroxidase levels between groups

  11. Thyroid autoimmunity-1

    Time frame: 90 days

    Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups

  12. Thyroid autoimmunity

    Time frame: 90 days

    Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups

  13. Adverse events of selenium

    Time frame: 45 days

  14. Adverse events of selenium

    Time frame: 90 days

  15. Clinical manifestatations of hyperthyroidism-2

    Time frame: 45 days

    Comparison of BMI between groups

  16. Clinical manifestations of hyperthyroidism-3

    Time frame: 45 days

    Comparison of total serum sex hormone binding globulin between groups

  17. Clinical manifestations of hyperthyroidism-4

    Time frame: 45 days

    Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 5, 2016
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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