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

NCT04682340 | Completed

• 1 other identifier: BPA-Thyroid
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism; Hyperthyroidism; Hashimoto Disease; Graves Disease

Keywords

bisphenol A; BPA; Hashimoto's Disease; Graves' Disease

Outcome Measures

Primary Outcomes (1)

• Comparison of serum BPA levels between the group with AITD and control group

  Dec 2020 - April 2021

Secondary Outcomes (1)

• The association between serum BPA levels and serum thyroid hormone levels in the AITD group

  Dec 2020 - April 2021

Study Arms (3)

Hashimoto's Group

Thyroid antibody positive and hypothyroidism

Diagnostic Test: Serum BPA

Graves' Group

Thyroid antibody positive and hyperthyroidism

Diagnostic Test: Serum BPA

Control Group

Thyroid antibody negative and euthyroidism

Diagnostic Test: Serum BPA

Interventions

Serum BPA DIAGNOSTIC_TEST

Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.

Control Group; Graves' Group; Hashimoto's Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College

Krakow, Malopolska, 31-591, Poland

Location

MeSH Terms

Conditions

Hypothyroidism; Hyperthyroidism; Hashimoto Disease; Graves Disease

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Thyroiditis, Autoimmune; Thyroiditis; Autoimmune Diseases; Immune System Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 23, 2020
• Study Start: December 22, 2020
• Primary Completion: October 30, 2021
• Study Completion: January 19, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)