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CompletedNCT04946123Updated Jun 8, 2025

Hyperthyroidism: Methimazole Plus L-carnitine and Selenium

An interventional study of L-carnitine+Selenium in Hyperthyroidism, sponsored by Lo.Li.Pharma s.r.l. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by Lo.Li.Pharma s.r.l · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium.

02

Conditions studied

  • Hyperthyroidism

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03

In context

Hyperthyroidism

112 studies on the registry are indexed under Hyperthyroidism; 27 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 61 interventional studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

Lo.Li.Pharma s.r.l is the lead sponsor of 30 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of hyperthyroidism requiring therapy with methimazole

Exclusion criteria

Exclusion Criteria:

  • Drug and alcohol abuse;
  • Pregnancy;
  • Medically uncontrolled psychiatric conditions;
  • Interfering therapies (lithium, interferone, TKI, amiodarone)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    methimazole (control)

    Patients with hyperthyroidism under methimazole treatment

  • Experimental
    methimazole+L-carnitine+selenium (intervention)

    Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium

    Dietary Supplement: L-carnitine+Selenium

Interventions

  • Dietary supplementL-carnitine+Selenium

    Drug pages: Carnitine · Selenium

    Supplementation with L-carnitine and Selenium

06

What researchers measure

Primary outcomes

  1. Hyperthyroidism symptoms

    Improvement of the patients' quality of life through questionnaire

    Time frame: Change from baseline QoL at 6 months of supplementation

  2. Hyperthyroidism symptoms

    Improvement of the patients' quality of life through questionnaire

    Time frame: Change from 6-months supplementation QoL at 12 months of intervention (end of study)

Secondary outcomes

  1. TRAb

    Change in serum TRAb (TSH receptor antibodies)

    Time frame: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)

  2. TSH

    Change in serum TSH (Thyroid stimulating hormone)

    Time frame: Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)

07

Study locations

1 site
  • Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino
    Torino, 10126, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04946123
Lead sponsor
Lo.Li.Pharma s.r.l
Responsible party
Sponsor
First posted
Jun 30, 2021
Start date
Jul 5, 2021
Primary completion
Jun 4, 2025
Completion
Jun 4, 2025
Last update
Jun 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Carnitine · Selenium

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