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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Graves Disease
• Hashimoto Disease
• Hyperthyroidism
• Hypothyroidism
• Thyroid Diseases

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