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Hyperthyroidism: Methimazole Plus L-carnitine and Selenium
Plain-language guide to NCT04946123: not phased randomized trial of L-Carnitine, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04946123
- Phase
- not phased
- Status
- completed
- Start
- 2021-07-05
- Completion (planned or actual)
- 2025-06-04
- Participants
- 60 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Hyperthyroidism
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test L-Carnitine.
It had two arms (groups): methimazole (control) (no intervention) and methimazole+L-carnitine+selenium (intervention) (experimental).
Patients with hyperthyroidism under methimazole treatment.
Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium.
The registry classes the interventions as dietary supplement.
Who Took Part
Enrollment: 60 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosis of hyperthyroidism requiring therapy with methimazole.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: drug and alcohol abuse;; medically uncontrolled psychiatric conditions;; interfering therapies (lithium, interferone, tki, amiodarone).
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.
The L-Carnitine group and the comparison group ran side by side rather than switching.
Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2021-07-05 with completion listed for 2025-06-04.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Hyperthyroidism symptoms (time frame: Change from baseline QoL at 6 months of supplementation). Hyperthyroidism symptoms (time frame: Change from 6-months supplementation QoL at 12 months of intervention (end of study)).
It also tracked 2 secondary outcomes, for example TRAb and TSH.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of L-Carnitine in 60 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, all human trials.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.