The role of TSH in the human immune system, a randomized, controlled, trial

Phase 2

Recruiting

• Conditions: T cell deficiency; 10021460

• Registration Number: NL-OMON33266
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

hypothyroidism for the last 6 months with only thyroxin substitution therapy
T3, T4 and TSH blood levels within the normal range for the past 6 months
TSH>20 mU/l at diagnosis
Presence of anti TPO antibodies
Age 20-45 years

Exclusion Criteria

Uncontrolled hypothyroidism
Presence of antibodies to the TSH receptor
History of M. Graves or thyroiditis
Presence of struma or an enlarged tyroid gland measured with ultrasound
Serious infections in the last 3 months
Thymectomy in the medical history
T cell affecting co-medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints of the study are a change in cell numbers or ratio*s of<br /><br>peripheral T cell subpopulations and changes in thymic output measured by naïve<br /><br>T cells and TREC analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary endpoints of the study are changes in lipid and bone metabolism,<br /><br>CK levels and metabolomics </p><br>