Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis

July 11, 2021 updated by: Guang Wang, Beijing Chao Yang Hospital
To evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In patients with autoimmune thyroiditis， investigators compared changes in thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping values and metabolic indicatorsfrom baseline to the end of treatment (12 weeks)

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
        • 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women between the ages of 18 and 75
  • Clinical diagnosis of autoimmune thyroiditis, serum TPOAb and TGAB positive
  • Thyroid function is normal, and no drugs affecting thyroid function such as Umetole and Serge have been used

Exclusion Criteria:

  • The contraindications indicated in the Chinese instructions of the drug
  • Hypothyroidism, hyperthyroidism
  • Liver function impairment
  • Renal function impairment
  • Claustrophobia
  • Mental disorders

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: selenium
selenium was administered to patients with autoimmune thyroiditis
Drug: Selenium
selenium 100ug ，take it orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti-thyroglobulin antibody changes
Time Frame: Changes from baseline and 3 months during follow-up
Changes from baseline and 3 months during follow-up
Changes from baseline and 3 months during follow-up
T1-mapping values of Thyroid MRI
Time Frame: Changes from baseline and 3 months during follow-up
Changes from baseline and 3 months during follow-up
Changes from baseline and 3 months during follow-up

Collaborators and Investigators

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

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Guang Wang, Beijing Chao Yang Hospital

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)

December 20, 2019

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-310

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.

Clinical Trials on Selenium

Clinical Trials on Selenium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe