Hyperthyroidism: Methimazole Plus L-carnitine and Selenium

• Sponsor: Lo.Li.Pharma s.r.l (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04946123
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperthyroidism	Dietary Supplement: L-carnitine+Selenium	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism
• Actual Study Start Date: Jul 5, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: methimazole (control) Patients with hyperthyroidism under methimazole treatment
Experimental: methimazole+L-carnitine+selenium (intervention) Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium	Dietary Supplement: L-carnitine+Selenium; Supplementation with L-carnitine and Selenium

Outcome Measures

Primary Outcome Measures

1. Hyperthyroidism symptoms [Change from baseline QoL at 6 months of supplementation]

   Improvement of the patients' quality of life through questionnaire

2. Hyperthyroidism symptoms [Change from 6-months supplementation QoL at 12 months of intervention (end of study)]

   Improvement of the patients' quality of life through questionnaire

Secondary Outcome Measures

1. 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)

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino	Torino		Italy	10126

Sponsors and Collaborators

• Lo.Li.Pharma s.r.l

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lo.Li.Pharma s.r.l
• ClinicalTrials.gov Identifier: NCT04946123
• Other Study ID Numbers: L-carnitine Hyperthyroidism
• First Posted: Jun 30, 2021
• Last Update Posted: Sep 8, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperthyroidism; Selenium

Study Results

No Results Posted as of Sep 8, 2021