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NCT04682340 Clinical Trial

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

Hypothyroidism Clinical Trial

Official title:
Analysis of Bisphenol A Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04682340
Other study ID # BPA-Thyroid
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 22, 2020
Est. completion date January 19, 2022

Study information
Verified date January 2022
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date January 19, 2022
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Serum BPA
Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.

Locations
Country Name City State
Poland Jagiellonian University Medical College Kraków Malopolska

Sponsors (1)
Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of serum BPA levels between the group with AITD and control group Dec 2020 - April 2021
Secondary The association between serum BPA levels and serum thyroid hormone levels in the AITD group To determine the association between serum BPA concentrations and serum thyroid hormone levels in adult women Dec 2020 - April 2021
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