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Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

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ClinicalTrials.gov Identifier: NCT02727738
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Marinò Michele, University of Pisa

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.

Condition or disease Intervention/treatment Phase
Graves' Disease Dietary Supplement: Selenium Drug: Methimazole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Open Clinical Study to Evaluate the Efficacy of Selenium Plus Methimazole for Treatment of Graves' Hyperthyroidism
Study Start Date : January 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperthyroidism
Drug Information available for: Methimazole

Arm Intervention/treatment
Experimental: Methimazole plus selenium
Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days
Dietary Supplement: Selenium
Selenium 80 mg bid for 90 days
Other Name: Syrel

Drug: 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
Other Name: Tapazole

Active Comparator: Methimazole
Methimazole 5-30 mg daily for 90 days
Drug: 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
Other Name: Tapazole




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperthyroid untreated Graves' disease patients

Exclusion Criteria:

  • Hyperthyroid treated Graves' disease patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727738


Locations
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Italy
Endocrinology Unit
Pisa, PI, Italy, 56124
Sponsors and Collaborators
University of Pisa
Investigators
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Principal Investigator: Claudio Marcocci, MD Department of Clinical and Experimental Medicine, University of Pisa
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Responsible Party: Marinò Michele, MD, University of Pisa
ClinicalTrials.gov Identifier: NCT02727738    
Other Study ID Numbers: UPisa
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marinò Michele, University of Pisa:
Hyperthyroidism
Methimazole
Selenium
Additional relevant MeSH terms:
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Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Selenium
Methimazole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists