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Completed

NCT Number: NCT04682340

Analysis of BPA 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.

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Key information

Conditions

Hypothyroidism Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hashimoto Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Jagiellonian University Medical College

Krakow, Malopolska, 31-591, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum BPA

Diagnostic Test

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

Primary outcomes

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

    Time frame: Dec 2020 - April 2021

Secondary outcomes

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

    Time frame: Dec 2020 - April 2021

    To determine the association between serum BPA concentrations and serum thyroid hormone levels in adult women

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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