Clinical trial NCT04682340: Analysis of BPA Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease
Official title: Analysis of Bisphenol A Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Hyperthyroidism
Hashimoto Disease
Graves Disease
Keywords: bisphenol A
BPA
Hashimoto's Disease
Graves' Disease
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of serum BPA levels between the group with AITD and control group
timeFrame: Dec 2020 - April 2021
Secondary outcomes:
measure: The association between serum BPA levels and serum thyroid hormone levels in the AITD group
timeFrame: Dec 2020 - April 2021
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
state: Malopolska
Study officials:
References: