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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothyroidism; Graves Disease; Hyperthyroidism; Hashimoto Disease
• Intervention / Treatment: Diagnostic test: Serum BPA

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Poland
  • Malopolska
    • Kraków, Malopolska, Poland, 31-591
      • Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women in the reproductive age from 18 to 45 years of age will be qualified to the study group. Women will be recruited from among patients admitted to the University Hospital in Krakow. After qualifying for the study, each patient will be collected demographic data, information about medical history and medications, as well as anthropometric data.During the medical visit, patients will be presented with all information about participation in the study and only those who give their informed consent in writing will be qualified for the study. Based on the clinical picture and the results of laboratory tests (the level of TSH, fT4 in the plasma and the presence of thyroid autoantibodies), the patients will be divided into 2 groups - 30 women with hyperthyroidism, 30 women with hypothyroidism. 20 healthy women without any thyroid dysfunction will be the control group. The groups will be matched according to age, body mass index and smoking.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hashimoto's Group; Thyroid antibody positive and hypothyroidism	Diagnostic test: Serum BPA; Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.
Graves' Group; Thyroid antibody positive and hyperthyroidism	Diagnostic test: Serum BPA; Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.
Control Group; Thyroid antibody negative and euthyroidism	Diagnostic test: Serum BPA; Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of serum BPA levels between the group with AITD and control group	Dec 2020 - April 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Graves' Disease; BPA; bisphenol A; Hashimoto's Disease
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Exophthalmos; Orbital Diseases; Goiter; Thyroiditis, Autoimmune; Thyroiditis; Hypothyroidism; Thyroid Diseases; Hyperthyroidism; Hashimoto Disease; Graves Disease
• Other Study ID Numbers: BPA-Thyroid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No