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

Primary Purpose

Selenium

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Selenium
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Selenium

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Chao-Yang Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

selenium

Arm Description

selenium was administered to patients with autoimmune thyroiditis

Outcomes

Primary Outcome Measures

anti-thyroglobulin antibody changes
Changes from baseline and 3 months during follow-up
T1-mapping values of Thyroid MRI
Changes from baseline and 3 months during follow-up

Secondary Outcome Measures

Full Information

First Posted
June 24, 2021
Last Updated
July 11, 2021
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04942769
Brief Title
Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis
Official Title
Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

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
To evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selenium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients with Autoimmune thyroiditis
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
selenium
Arm Type
Experimental
Arm Description
selenium was administered to patients with autoimmune thyroiditis
Intervention Type
Drug
Intervention Name(s)
Selenium
Intervention Description
selenium 100ug ，take it orally twice daily
Primary Outcome Measure Information:
Title
anti-thyroglobulin antibody changes
Description
Changes from baseline and 3 months during follow-up
Time Frame
Changes from baseline and 3 months during follow-up
Title
T1-mapping values of Thyroid MRI
Description
Changes from baseline and 3 months during follow-up
Time Frame
Changes from baseline and 3 months during follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Liu, MD
Phone
861085231710
Email
liujia0116@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomeng Sun
Phone
861085231711
Email
beijingxiaosun2010@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Wang
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia liu, MD
Phone
861085231710
Email
liujia0116@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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