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

Selenium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942769
• Other study ID #: 2021-310
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: July 2021
• Source: Beijing Chao Yang Hospital
• Contact: Jia Liu, MD
• Phone: 861085231710
• Email: liujia0116[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hashimoto Disease
• Selenium
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Drug:
• Selenium
selenium 100ug ,take it orally twice daily

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-thyroglobulin antibody changes	Changes from baseline and 3 months during follow-up	Changes from baseline and 3 months during follow-up
Primary	T1-mapping values of Thyroid MRI	Changes from baseline and 3 months during follow-up	Changes from baseline and 3 months during follow-up