Hyperthyroidism: Methimazole Plus L-carnitine and Selenium

August 31, 2021 updated by: Lo.Li.Pharma s.r.l

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperthyroidism symptoms
Time Frame: Change from baseline QoL at 6 months of supplementation
Improvement of the patients' quality of life through questionnaire
Change from baseline QoL at 6 months of supplementation
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
Change from 6-months supplementation QoL at 12 months of intervention (end of study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TRAb
Time Frame: 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)
Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
TSH
Time Frame: 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)
Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-carnitine Hyperthyroidism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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