Study on the Effect of Selenium Supplementation on the St... | NCT04942769

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

NCT04942769

Sponsor

Beijing Chao Yang Hospital

Status

Unknown status

Last Update Posted

Jul 16, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Selenium

Interventions

Selenium

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2019Actual

Primary Completion Date

Jul 30, 2021Estimated

Completion Date

Oct 30, 2021Estimated

First Submitted Date

Jun 24, 2021

First Submission Date that Met QC Criteria

Jun 24, 2021

First Posted Date

Jun 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2021

Last Update Posted Date

Jul 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guang Wang, Professor and Director, Department of Endocrinology, Beijing Chao Yang HospitalPrincipal Investigator

Lead Sponsor

Beijing Chao Yang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
selenium	Experimental	selenium was administered to patients with autoimmune thyroiditis	Drug: Selenium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Selenium	Drug	selenium 100ug ，take it orally twice daily	selenium

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jia Liu, MD	Contact	861085231710		liujia0116@126.com
Xiaomeng Sun	Contact	861085231711		beijingxiaosun2010@163.com

Overall Officials

Name	Affiliation	Role
Guang Wang	Beijing Chao Yang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Chao-Yang Hospital, Capital Medical University	Recruiting	Beijing	Beijing Municipality		China

Intervention Browse Module

MeSH Terms

ID	Term
D012643	Selenium

Ancestor Terms

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D008903	Minerals

Browse Leaves

Not provided

Browse Branches

Not provided