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

• Sponsor: Jagiellonian University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04682340
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothyroidism; Hyperthyroidism; Hashimoto Disease; Graves Disease	Diagnostic Test: Serum BPA

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Analysis of Bisphenol A Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease
• Actual Study Start Date: Dec 22, 2020
• Actual Primary Completion Date: Oct 30, 2021
• Actual Study Completion Date: Jan 19, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Comparison of serum BPA levels between the group with AITD and control group [Dec 2020 - April 2021]

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jagiellonian University Medical College	Kraków	Malopolska	Poland	31-591

Sponsors and Collaborators

• Jagiellonian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karolina Zawadzka, Principal Investigator, Jagiellonian University
• ClinicalTrials.gov Identifier: NCT04682340
• Other Study ID Numbers: BPA-Thyroid
• First Posted: Dec 23, 2020
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Karolina Zawadzka, Principal Investigator, Jagiellonian University: bisphenol A; BPA; Hashimoto's Disease; Graves' Disease
• Additional relevant MeSH terms: Graves Disease; Hypothyroidism; Thyroid Diseases; Hyperthyroidism; Hashimoto Disease

Study Results

No Results Posted as of Jan 21, 2022