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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04946123
Other study ID # L-carnitine Hyperthyroidism
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 5, 2021
Est. completion date July 2022

Study information

Verified date August 2021
Source Lo.Li.Pharma s.r.l
Contact Loredana Pagano, MD
Phone +39 339 6918551
Email lpagano@cittadellasalute.to.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
L-carnitine+Selenium
Supplementation with L-carnitine and Selenium

Locations

Country Name City State
Italy Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino Torino

Sponsors (1)

Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hyperthyroidism symptoms Improvement of the patients' quality of life through questionnaire Change from baseline QoL at 6 months of supplementation
Primary Hyperthyroidism symptoms Improvement of the patients' quality of life through questionnaire Change from 6-months supplementation QoL at 12 months of intervention (end of study)
Secondary TRAb Change in serum TRAb (TSH receptor antibodies) Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
Secondary TSH Change in serum TSH (Thyroid stimulating hormone) Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
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