NCT04942769

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 20, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

June 24, 2021

Last Update Submit

July 11, 2021

Conditions

Selenium

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

selenium

EXPERIMENTAL

selenium was administered to patients with autoimmune thyroiditis

Drug: Selenium

Interventions

SeleniumDRUG

selenium 100ug ，take it orally twice daily

selenium

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Interventions

Selenium

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Guang Wang

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Liu, MD

CONTACT

861085231710liujia0116@126.com

Xiaomeng Sun

CONTACT

861085231711beijingxiaosun2010@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: patients with Autoimmune thyroiditis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Department of Endocrinology

Study Record Dates

First Submitted

June 24, 2021

First Posted

June 28, 2021

Study Start

December 20, 2019

Primary Completion

July 30, 2021

Study Completion

October 30, 2021

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

CN(1)