Graves' DiseaseNCT02727738
Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole
A study testing Selenium and Methimazole in people with Graves' Disease, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Graves' Disease
- What is being tested?
- Selenium and Methimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperthyroid untreated Graves' disease patients
Who cannot join
- Hyperthyroid treated Graves' disease patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Open Clinical Study to Evaluate the Efficacy of Selenium Plus Methimazole for Treatment of Graves' Hyperthyroidism
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.
Read the 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
- Being tested
- Selenium, Methimazole
- Keywords
- Hyperthyroidism, Methimazole, Selenium
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
Also called Syrel
Selenium 80 mg bid for 90 days
MethimazoleDrug
Also called Tapazole
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
| Study group | Role | What they receive |
|---|---|---|
| Methimazole plus selenium | Experimental | Methimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days Receives: Dietary Supplement: Selenium; Drug: Methimazole |
| Methimazole | Active comparator | Methimazole 5-30 mg daily for 90 days Receives: Drug: Methimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of hyperthyroidism
Comparison of FT3 and FT4 values (pg/ml) between groups
Measured: 90 days
Clinical manifestations of hyperthyroidism-1
Comparison of heart rate between groups
Measured: 90 days
Clinical manifestations of hyperthyroidism-2
Comparison of BMI between groups
Measured: 90 days
Clinical manifestations of hyperthyroidism-3
Comparison of total serum cholesterol between groups
Measured: 90 days
Clinical manifestations of hyperthyroidism-4
Comparison of total serum sex hormone binding globulin between groups
Measured: 90 days
Clinical manifestations of hyperthyroidism-5
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Measured: 90 days
Secondary outcomes (17)
Control of hyperthyroidism
Comparison of FT3 and FT4 values (pg/ml) between groups
Measured: 45 days
Clinical manifestations of hyperthyroidism-1
Comparison of heart rate between groups
Measured: 45 days
Selenium levels
Comparison of serum selenium levels between groups
Measured: 45 days
Selenium levels
Comparison of serum selenium levels between groups
Measured: 90 days
Oxidative stress parameters-1
Comparison of serum malondialdehyde levels between groups
Measured: 45 days
Oxidative stress parameters-2
Comparison of serum glutathione peroxidase levels between groups
Measured: 45 days
Thyroid autoimmunity-1
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Measured: 45 days
Thyroid autoimmunity-2
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Measured: 45 days
Oxidative stress parameters-1
Comparison of serum malondialdehyde levels between groups
Measured: 90 days
Oxidative stress parameters-2
Comparison of serum glutathione peroxidase levels between groups
Measured: 90 days
Thyroid autoimmunity-1
Comparison of serum anti-thyroperoxidase antibodies levels and prevalence between groups
Measured: 90 days
Thyroid autoimmunity
Comparison of serum anti-thyrotropin receptor antibodies levels and prevalence between groups
Measured: 90 days
Adverse events of selenium
Measured: 45 days
Adverse events of selenium
Measured: 90 days
Clinical manifestatations of hyperthyroidism-2
Comparison of BMI between groups
Measured: 45 days
Clinical manifestations of hyperthyroidism-3
Comparison of total serum sex hormone binding globulin between groups
Measured: 45 days
Clinical manifestations of hyperthyroidism-4
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marinò Michele, University of Pisa
- Investigators
- Claudio Marcocci, MD, Principal investigator, Department of Clinical and Experimental Medicine, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727738
- Sponsor's protocol ID
- UPisa
- Status last verified
- Apr 2016
- First submitted
- 30 Jun 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Clinical Study to Evaluate the Efficacy of Selenium Plus Methimazole for Treatment of Graves' Hyperthyroidism
- ClinicalTrials.gov ID
- NCT02727738
- Acronym / sponsor ID
- UPisa
- Conditions
- Graves' Disease
- Keywords
- Hyperthyroidism, Methimazole, Selenium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methimazole plus selenium | Experimental | Dietary Supplement: Selenium, Drug: MethimazoleMethimazole 5-30 mg daily for 90 days Selenium 80 bid for 90 days |
| Methimazole | Active comparator | Drug: MethimazoleMethimazole 5-30 mg daily for 90 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hyperthyroid untreated Graves' disease patients
Key exclusion criteria (1 listed)
- Hyperthyroid treated Graves' disease patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeleniumAlso: SyrelSelenium 80 mg bid for 90 days | Dietary supplement | Methimazole plus selenium |
| MethimazoleAlso: TapazoleMethimazole 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 | Drug | Methimazole, Methimazole plus selenium |
Primary outcome
Control of hyperthyroidism
Time frame: 90 days
Comparison of FT3 and FT4 values (pg/ml) between groups
Clinical manifestations of hyperthyroidism-1
Time frame: 90 days
Comparison of heart rate between groups
Clinical manifestations of hyperthyroidism-2
Time frame: 90 days
Comparison of BMI between groups
Clinical manifestations of hyperthyroidism-3
Time frame: 90 days
Comparison of total serum cholesterol between groups
Clinical manifestations of hyperthyroidism-4
Time frame: 90 days
Comparison of total serum sex hormone binding globulin between groups
Clinical manifestations of hyperthyroidism-5
Time frame: 90 days
Comparison of subjective hyperthyroidism symptoms score collected by questionnaire between groups
17 secondary outcomes
Control of hyperthyroidism
Time frame: 45 days
Clinical manifestations of hyperthyroidism-1
Time frame: 45 days
Selenium levels
Time frame: 45 days
Selenium levels
Time frame: 90 days
Oxidative stress parameters-1
Time frame: 45 days
Oxidative stress parameters-2
Time frame: 45 days
Thyroid autoimmunity-1
Time frame: 45 days
Thyroid autoimmunity-2
Time frame: 45 days
Oxidative stress parameters-1
Time frame: 90 days
Oxidative stress parameters-2
Time frame: 90 days
Thyroid autoimmunity-1
Time frame: 90 days
Thyroid autoimmunity
Time frame: 90 days
Adverse events of selenium
Time frame: 45 days
Adverse events of selenium
Time frame: 90 days
Clinical manifestatations of hyperthyroidism-2
Time frame: 45 days
Clinical manifestations of hyperthyroidism-3
Time frame: 45 days
Clinical manifestations of hyperthyroidism-4
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Graves' Disease
RecruitingPhase 2
Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Graves' Disease
RecruitingPhase 2
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Graves' Disease
RecruitingPhase 1
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
Graves Disease
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Graves' Disease
Not yet recruitingPhase 2/3
An Open-Label Study to Determine if BHV-1300 is Safe in Adults With Graves' Disease
Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Marcocci, MD principal investigator
Department of Clinical and Experimental Medicine, University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium and Methimazole in people with Graves' Disease, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of hyperthyroidism (time frame: 90 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.