Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Subclinical Hypothyroidisms

Treatments: Drug: Levothyroxine Sodium Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04953195

2021-309

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

levothyroxine sodium

Experimental group

Description:

levothyroxine sodium

Treatment:

Drug: Levothyroxine Sodium Tablets