NCT04946123

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 5, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

June 15, 2021

Last Update Submit

June 4, 2025

Conditions

Hyperthyroidism

Outcome Measures

Primary Outcomes (2)

  • Hyperthyroidism symptoms

    Improvement of the patients' quality of life through questionnaire

    Change from baseline QoL at 6 months of supplementation

  • 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 Outcomes (2)

  • TRAb

    Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)

  • TSH

    Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months)

Study Arms (2)

methimazole (control)

NO INTERVENTION

Patients with hyperthyroidism under methimazole treatment

methimazole+L-carnitine+selenium (intervention)

EXPERIMENTAL

Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium

Dietary Supplement: L-carnitine+Selenium

Interventions

L-carnitine+SeleniumDIETARY_SUPPLEMENT

Supplementation with L-carnitine and Selenium

methimazole+L-carnitine+selenium (intervention)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hyperthyroidism requiring therapy with methimazole

You may not qualify if:

  • Drug and alcohol abuse;
  • Pregnancy;
  • Medically uncontrolled psychiatric conditions;
  • Interfering therapies (lithium, interferone, TKI, amiodarone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Città della scienza e degli studi di Torino

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 30, 2021

Study Start

July 5, 2021

Primary Completion

June 4, 2025

Study Completion

June 4, 2025

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)