Back to resultsThyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
Primary Purpose
Subclinical Hypothyroidisms
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Levothyroxine Sodium Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Subclinical Hypothyroidisms
Eligibility Criteria
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
Sites / Locations
- Beijing Chao-Yang Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
levothyroxine sodium
Arm Description
levothyroxine sodium
Outcomes
Primary Outcome Measures
Thyroid Stimulating Hormone changes
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
T1-mapping values of Thyroid MRI
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
Secondary Outcome Measures
anti-thyroid peroxidase antibody changes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04953195
Brief Title
Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
Official Title
Effect of Thyroid Replacement Therapy on Thyroid Structure in Patients With Subclinical Hypothyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subclinical Hypothyroidisms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
levothyroxine sodium
Arm Type
Experimental
Arm Description
levothyroxine sodium
Intervention Type
Drug
Intervention Name(s)
Levothyroxine Sodium Tablets
Intervention Description
Levothyroxine Sodium(50ug/Tablets,dosage form 25ug,once a day) was administered to patients with autoimmune thyroiditis with mild subclinical hypothyroidism,
Primary Outcome Measure Information:
Title
Thyroid Stimulating Hormone changes
Description
Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
Time Frame
Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
Title
free thyroxine changes
Description
free thyroxine changes from baseline and 12 weeks during follow-up
Time Frame
free thyroxine changes from baseline and 12 weeks during follow-up
Title
T1-mapping values of Thyroid MRI
Description
T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
Time Frame
T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
Title
Free triiodothyronine changes
Description
Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
Time Frame
Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
Secondary Outcome Measure Information:
Title
anti-thyroid peroxidase antibody changes
Description
anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
Time Frame
anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
Title
anti-thyroglobulin antibody changes
Description
anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up
Time Frame
anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Liu, MD
Phone
861085231710
Email
liujia0116@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomeng Sun, MD
Phone
861085231711
Email
beijingxiaosun2010@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Wang, MD
Organizational Affiliation
Beijing Chao-Yang Hospital, Capital Medical University, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia liu, MD
Phone
861085231710
Email
liujia0116@126.com
12. IPD Sharing Statement
Learn more about this trial
Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
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