Analysis of BPA Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease

Completed

• Conditions: Graves Disease; Hypothyroidism; Hyperthyroidism; Hashimoto Disease
• Interventions: Diagnostic Test: Serum BPA

• Registration Number: NCT04682340
• Lead Sponsor: Jagiellonian University

Brief Summary

The aim of the study is to assess the relationship between the concentration of bisphenol A in serum and selected parameters of thyroid function in women of reproductive age with thyroid dysfunction - Hashimoto's disease and Graves' disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-18
• Study Start: 2020-12-22
• Study First Posted: 2020-12-23
• Primary Completion: 2021-10-30
• Status Verified: 2022-01
• Study Completion: 2022-01-19
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Graves' disease or Hashimoto's disease (positive thyroid autoantibody)
• Control group: thyroid autoantibody negative, normal thyroid function
• Women aged 18 to 45 in both the control group and experimental group

Exclusion Criteria

• Pregnancy and lactating women
• Previous or planned treatment with 131I or thyroidectomy
• The use of drugs affecting the thyroid function (lithium, amiodarone, interferon a, sodium nitroprusside, sunitinib, sorafenib, iodine contrast, antibiotics / antifungals / antivirals (for at least 4 weeks prior to recruitment to the study), which do not result from the treatment of thyroid disease (levothyroxine, thyreostatic drugs, glucocorticoids)
• Active malignancy
• Other autoimmune diseases
• Other endocrine diseases
• Patients with severe liver, kidney or heart failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Serum BPA	Thyroid antibody negative and euthyroidism
Graves' Group	Serum BPA	Thyroid antibody positive and hyperthyroidism
Hashimoto's Group	Serum BPA	Thyroid antibody positive and hypothyroidism

Primary Outcome Measures

Name	Time	Method
Comparison of serum BPA levels between the group with AITD and control group	Dec 2020 - April 2021

Secondary Outcome Measures

Name	Time	Method
The association between serum BPA levels and serum thyroid hormone levels in the AITD group	Dec 2020 - April 2021	To determine the association between serum BPA concentrations and serum thyroid hormone levels in adult women

Trial Locations

Locations (1)

Jagiellonian University Medical College; 🇵🇱 Kraków, Malopolska, Poland