HyperthyroidismNCT04946123
Hyperthyroidism: Methimazole Plus L-carnitine and Selenium
A study testing L-carnitine+Selenium in people with Hyperthyroidism, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- L-carnitine+Selenium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jul 2021to 4 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hyperthyroidism requiring therapy with methimazole
Who cannot join
- Drug and alcohol abuse;
- Pregnancy;
- Medically uncontrolled psychiatric conditions;
- Interfering therapies (lithium, interferone, TKI, amiodarone)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino
Torino, 10126
About this study
Official title: Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism
The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium.
- Conditions
- Hyperthyroidism
- Being tested
- L-carnitine+Selenium
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine+SeleniumDietary supplement
Supplementation with L-carnitine and Selenium
| Study group | Role | What they receive |
|---|---|---|
| methimazole (control) | No intervention | Patients with hyperthyroidism under methimazole treatment |
| methimazole+L-carnitine+selenium (intervention) | Experimental | Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium Receives: Dietary Supplement: L-carnitine+Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperthyroidism symptoms
Improvement of the patients' quality of life through questionnaire
Measured: Change from baseline QoL at 6 months of supplementation
Hyperthyroidism symptoms
Improvement of the patients' quality of life through questionnaire
Measured: Change from 6-months supplementation QoL at 12 months of intervention (end of study)
Secondary outcomes (2)
TRAb
Change in serum TRAb (TSH receptor antibodies)
Measured: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
TSH
Change in serum TSH (Thyroid stimulating hormone)
Measured: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start5 Jul 2021
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946123
- Sponsor's protocol ID
- L-carnitine Hyperthyroidism
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism
- ClinicalTrials.gov ID
- NCT04946123
- Acronym / sponsor ID
- L-carnitine Hyperthyroidism
- Conditions
- Hyperthyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 30 Jun 2021 (actual)
- 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.
The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methimazole (control) | No intervention | –Patients with hyperthyroidism under methimazole treatment |
| methimazole+L-carnitine+selenium (intervention) | Experimental | Dietary Supplement: L-carnitine+SeleniumPatients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of hyperthyroidism requiring therapy with methimazole
Key exclusion criteria (4 listed)
- Drug and alcohol abuse;
- Pregnancy;
- Medically uncontrolled psychiatric conditions;
- Interfering therapies (lithium, interferone, TKI, amiodarone)
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 |
|---|---|---|
| L-carnitine+SeleniumSupplementation with L-carnitine and Selenium | Dietary supplement | methimazole+L-carnitine+selenium (intervention) |
Primary outcome
Hyperthyroidism symptoms
Time frame: Change from baseline QoL at 6 months of supplementation
Improvement of the patients' quality of life through questionnaire
Hyperthyroidism symptoms
Time frame: Change from 6-months supplementation QoL at 12 months of intervention (end of study)
Improvement of the patients' quality of life through questionnaire
2 secondary outcomes
TRAb
Time frame: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
TSH
Time frame: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
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 8 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine+Selenium in people with Hyperthyroidism, run by Lo.Li.Pharma s.r.l 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 4 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 8 Jun 2025. 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?
Hyperthyroidism symptoms (time frame: Change from baseline QoL at 6 months of supplementation). The study lists 2 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 8 Jun 2025.