Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism

Effect of Thyroid Replacement Therapy on Thyroid Structure in Patients With Subclinical Hypothyroidism

The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)

Study Overview

• Status: Recruiting
• Conditions: Subclinical Hypothyroidisms
• Intervention / Treatment: Drug: Levothyroxine Sodium Tablets

Detailed Description

In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jia liu, MD; Phone Number: 861085231710; Email: liujia0116@126.com
• Study Contact Backup: Name: Xiaomeng Sun, MD; Phone Number: 861085231711; Email: beijingxiaosun2010@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing CHAO-YANG Hospital, Capital Medical University
      • Contact: Jia liu, MD; Phone Number: 861085231710; Email: liujia0116@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women between the ages of 18 and 75;
• Diagnostic criteria for mild subclinical hypothyroidism :TSH>10mIU/L, thyroxine and free thyroxine levels were normal
• Positive thyroglobulin antibody and/or Thyroperoxidase antibody
• No previous use of drugs affecting thyroid function

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: levothyroxine sodium	Drug: Levothyroxine Sodium Tablets; Levothyroxine Sodium(50ug/Tablets,dosage form 25ug,once a day) was administered to patients with autoimmune thyroiditis with mild subclinical hypothyroidism,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid Stimulating Hormone changes	Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up	Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
free thyroxine changes	free thyroxine changes from baseline and 12 weeks during follow-up	free thyroxine changes from baseline and 12 weeks during follow-up
T1-mapping values of Thyroid MRI	T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up	T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
Free triiodothyronine changes	Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up	Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anti-thyroid peroxidase antibody changes	anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up	anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
anti-thyroglobulin antibody changes	anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up	anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: Guang Wang, MD, Beijing Chao-Yang Hospital, Capital Medical University, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): September 15, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 3, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: 2021-309

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No