NCT04946123CompletedNot Applicable
Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lo.Li.Pharma s.r.l
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Hyperthyroidism symptoms
Study Overview
Brief Summary
The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of hyperthyroidism requiring therapy with methimazole
Exclusion Criteria
- •Drug and alcohol abuse;
- •Pregnancy;
- •Medically uncontrolled psychiatric conditions;
- •Interfering therapies (lithium, interferone, TKI, amiodarone)
Arms & Interventions
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
Intervention: L-carnitine+Selenium (Dietary Supplement)
Outcomes
Primary Outcomes
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
Hyperthyroidism symptoms
Time Frame: Change from baseline QoL at 6 months of supplementation
Improvement of the patients' quality of life through questionnaire
Secondary Outcomes
- TRAb(Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months))
- TSH(Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months))
Investigators
Study Sites (1)
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