Back to resultsHyperthyroidism: Methimazole Plus L-carnitine and Selenium
Primary Purpose
Hyperthyroidism
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
L-carnitine+Selenium
Sponsored by
About this trial
This is an interventional treatment trial for Hyperthyroidism
Eligibility Criteria
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)
Sites / Locations
- Azienda Ospedaliero-Universitaria Città della scienza e degli studi di TorinoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
methimazole (control)
methimazole+L-carnitine+selenium (intervention)
Arm Description
Patients with hyperthyroidism under methimazole treatment
Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium
Outcomes
Primary Outcome Measures
Hyperthyroidism symptoms
Improvement of the patients' quality of life through questionnaire
Hyperthyroidism symptoms
Improvement of the patients' quality of life through questionnaire
Secondary Outcome Measures
TRAb
Change in serum TRAb (TSH receptor antibodies)
TSH
Change in serum TSH (Thyroid stimulating hormone)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04946123
Brief Title
Hyperthyroidism: Methimazole Plus L-carnitine and Selenium
Official Title
Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
methimazole (control)
Arm Type
No Intervention
Arm Description
Patients with hyperthyroidism under methimazole treatment
Arm Title
methimazole+L-carnitine+selenium (intervention)
Arm Type
Experimental
Arm Description
Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine+Selenium
Intervention Description
Supplementation with L-carnitine and Selenium
Primary Outcome Measure Information:
Title
Hyperthyroidism symptoms
Description
Improvement of the patients' quality of life through questionnaire
Time Frame
Change from baseline QoL at 6 months of supplementation
Title
Hyperthyroidism symptoms
Description
Improvement of the patients' quality of life through questionnaire
Time Frame
Change from 6-months supplementation QoL at 12 months of intervention (end of study)
Secondary Outcome Measure Information:
Title
TRAb
Description
Change in serum TRAb (TSH receptor antibodies)
Time Frame
Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
Title
TSH
Description
Change in serum TSH (Thyroid stimulating hormone)
Time Frame
Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loredana Pagano, MD
Phone
+39 339 6918551
Email
lpagano@cittadellasalute.to.it
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loredana Pagano, Dr
Phone
+39 3396918551
Email
lpagano@cittadellasalute.to.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperthyroidism: Methimazole Plus L-carnitine and Selenium
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