Hemostatic effects of levothyroxine and selenomethionine in euthyroid women with Hashimoto's thyroiditis

Phase 4

Completed

• Conditions: Chronic lymphocytic thyroiditis, often referred to as Hashimoto's thyroiditis; Metabolic and Endocrine - Thyroid disease

• Registration Number: ACTRN12612000271808
• Lead Sponsor: the Polish Committee of Scientific Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 155

Inclusion Criteria

(a) positive antibodies (>100 U/mL) against thyroid peroxidase (TPOAb), (b) the reduced echogenicity of the thyroid parenchyma on thyroid ultrasonography, (c) serum TSH less than 4.0 mU/L, and (d) plasma levels of free thyroxine (fT4) and free triiodothyronine (fT3)) within the reference range

Exclusion Criteria

A) any acute and chronic inflammatory processes
B) other autoimmune disorders
C) positive serum antibodies against TSH receptor
D) current treatment with thyroid hormones
E) concomitant treatment with drugs that may affect inflammatory processes in the vascular wall
F) concomitant treatment with other drugs known either to affect thyroid hormones or to interact with levothyroxine and selenomethionine
G) BMI>40 kg/m2
H) Turner or Down syndrome
I) any form of coronary artery disease
J) moderate or severe arterial hypertension (ESC/ESH grade 2 or 3)
K) symptomatic congestive heart failure
L) diabetes, impaired glucose tolerance or impaired fasting glucose
M) impaired renal or hepatic function
N) pregnancy or lactation
O) poor patient compliance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma levels of fibrinogen (blood analysis)[Timepoint: at baseline and after three and six months of treatment];Factor VII coagulant activity (blood analysis)[Timepoint: at baseline and after three and six months of treatment];Plasma levels of plasminogen activator inhibitor-1 (blood analysis)[Timepoint: at baseline and after three and six months of treatment]

Secondary Outcome Measures

Name	Time	Method
The international normalized ratio (blood analysis)[Timepoint: at baseline and after three and six months of treatment];The activated partial prothrombin time (blood analysis)[Timepoint: at baseline and after three and six months of treatment];Plasma levels of von Willebrand factor (blood analysis)[Timepoint: at baseline and after three and six months of treatment];Plasma levels of factor X (blood analysis)[Timepoint: at baseline and after three and six months of treatment]