Hyperthyroidism: Methimazole Plus L-carnitine and Selenium

Hyperthyroidism Clinical Trial

Official title:

Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946123
• Other study ID #: L-carnitine Hyperthyroidism
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Hyperthyroidism

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)