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

• Sponsor: Beijing Chao Yang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04942769
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22.3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Selenium	Drug: Selenium	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: patients with Autoimmune thyroiditispatients with Autoimmune thyroiditis
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis
• Actual Study Start Date: Dec 20, 2019
• Anticipated Primary Completion Date: Jul 30, 2021
• Anticipated Study Completion Date: Oct 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. anti-thyroglobulin antibody changes [Changes from baseline and 3 months during follow-up]

   Changes from baseline and 3 months during follow-up

2. T1-mapping values of Thyroid MRI [Changes from baseline and 3 months during follow-up]

   Changes from baseline and 3 months during follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing	China

Sponsors and Collaborators

• Beijing Chao Yang Hospital

Investigators

• Principal Investigator: Guang Wang, Beijing Chao Yang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guang Wang, Professor and Director, Department of Endocrinology, Beijing Chao Yang Hospital
• ClinicalTrials.gov Identifier: NCT04942769
• Other Study ID Numbers: 2021-310
• First Posted: Jun 28, 2021
• Last Update Posted: Jul 16, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease; Selenium

Study Results

No Results Posted as of Jul 16, 2021