HypothyroidismNCT04682340
Analysis of BPA Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease
An observational study of Hypothyroidism and Hyperthyroidism, run by Jagiellonian University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypothyroidism, Hyperthyroidism, Hashimoto Disease
- What is being tested?
- Serum BPA
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 22 Dec 2020to 19 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College
Krakow, Malopolska, 31-591
About this study
Official title: Analysis of Bisphenol A 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.
- Conditions
- Hypothyroidism, Hyperthyroidism, Hashimoto Disease, Graves Disease
- Being tested
- Serum BPA
- Keywords
- bisphenol A, BPA, Hashimoto's Disease, Graves' Disease
- Medical subject headings
- Hypothyroidism, Hyperthyroidism, Hashimoto Disease, Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum BPADiagnostic test
Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.
| Study group | Role | What they receive |
|---|---|---|
| Hashimoto's Group | Thyroid antibody positive and hypothyroidism Receives: Diagnostic Test: Serum BPA | |
| Graves' Group | Thyroid antibody positive and hyperthyroidism Receives: Diagnostic Test: Serum BPA | |
| Control Group | Thyroid antibody negative and euthyroidism Receives: Diagnostic Test: Serum BPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum BPA levels between the group with AITD and control group
Measured: Dec 2020 - April 2021
Secondary outcomes (1)
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
Measured: Dec 2020 - April 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start22 Dec 2020
- Primary completion30 Oct 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Zawadzka, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682340
- Sponsor's protocol ID
- BPA-Thyroid
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Bisphenol A Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease
- ClinicalTrials.gov ID
- NCT04682340
- Acronym / sponsor ID
- BPA-Thyroid
- Conditions
- Hypothyroidism, Hyperthyroidism, Hashimoto Disease, Graves Disease
- Keywords
- bisphenol A, BPA, Hashimoto's Disease, Graves' Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hashimoto's Group | – | Diagnostic Test: Serum BPAThyroid antibody positive and hypothyroidism |
| Graves' Group | – | Diagnostic Test: Serum BPAThyroid antibody positive and hyperthyroidism |
| Control Group | – | Diagnostic Test: Serum BPAThyroid antibody negative and euthyroidism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum BPASerum BPA levels will be compared between women with autoimmune thyroid disease and normal women. | Diagnostic test | Control Group, Graves' Group, Hashimoto's Group |
Primary outcome
Comparison of serum BPA levels between the group with AITD and control group
Time frame: Dec 2020 - April 2021
1 secondary outcome
The association between serum BPA levels and serum thyroid hormone levels in the AITD group
Time frame: Dec 2020 - April 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism and Hyperthyroidism, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of serum BPA levels between the group with AITD and control group (time frame: Dec 2020 - April 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.