Hyperthyroidism
Conditions
Brief summary
The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium.
Interventions
DIETARY_SUPPLEMENTL-carnitine+Selenium
Supplementation with L-carnitine and Selenium
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperthyroidism symptoms | Change from baseline QoL at 6 months of supplementation | Improvement of the patients' quality of life through questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TRAb | Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months) | Change in serum TRAb (TSH receptor antibodies) |
| TSH | Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months) | Change in serum TSH (Thyroid stimulating hormone) |
Countries
Italy
Outcome results
None listed