The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in 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: ACTRN12611000238976
• 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: 2011-03-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 211

Inclusion Criteria

Hashimoto's thyroiditis patients:
A) females between the ages of 18 and 60 years
B) positive antibodies (>100 U/mL) against thyroid peroxidase
C) the reduced echogenicity of the thyroid parenchyma on thyroid ultrasonography
D) euthyroid function (TSH < 4.0 mU/L, normal values for free thyroxine and free triiodothyronine)

Control Group II:
age-, weight-, blood pressure-, and lipid-profile-matched healthy women

Participants were medically stable, and, in the judgment of the investigators, otherwise acceptable for entry on the basis of the findings of medical history, physical examination, and routine laboratory tests

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
Primary Outcome 1: Monocyte release of tumor necrosis factor-alpha, interleukin-1beta, interleukin-6, monocyte chemoattractant protein-1 (cell cultures, assays in supernatants, ELISA method)[Timepoint: at baseline and after three and six months of treatment];Primary Outcome 2: Lymphocyte release of tumor necrosis factor-alpha, interleukin-2, interferon-gamma (cell cultures, assays in supernatants, ELISA method)[Timepoint: at baseline and after three and six months of treatment];Primary Outcome 3: Plasma levels of high sensitivity C-reactive protein (cell cultures, assays in supernatants, ELISA method)[Timepoint: at baseline and after three and six months of treatment]

Secondary Outcome Measures

Name	Time	Method
Monocyte and lymphocyte release of proinflammatory cytokines and plasma levels of hsCRP between smokers and non-smokers (cell cultures, assays in supernatants, ELISA method)[Timepoint: at baseline and after three and six months of treatment]