The Effect of Iodine and BPA on AITD in Reproduction WomenNCT03932487
The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women
An observational study of The Effect of Iodine and BPA on AITD in Reproduction Women, run by Xiaomei Zhang at 1 site in China.
Trial summary
Autoimmune thyroid disease (AITD) is the main cause of hypothyroidism in reproduction women, iodine and bisphenol A are the environmental factors for AITD. The research was mainly designed to investigate the effect of iodine and BPA on AITD in reproduction women to provide new evidence for hypothyroidism in… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- The Effect of Iodine and BPA on AITD in Reproduction Women
- What is being tested?
- urinary iodine and urine BPA
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2019to 1 Oct 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In Peking University international hospital women of childbearing age (age 20 to 45 years old) of 142 cases of 71 patients with thyroid autoantibodies positive as AITD group, the other selected 71 cases of healthy women of childbearing age as normal group, record the age, BMI, and examination of the history of history of thyroid disease, family history and whether the application of iodized salt and other general information and we, thyroid autoantibodies detection results, urine iodine, urinary iodine/urinary creatinine and urinary BPA and urinary BPA/creatinine detection.
Who may be able to join
- AITD group: positive thyroid autoantibody (one thyroid autoantibody), normal thyroid function.
- Normal group: thyroid autoantibody negative, normal thyroid function.
- No previous history of hyperthyroidism or hypothyroidism, no history of thyroid surgery or I131 radiotherapy, and no thyroid hormone or anti-thyroid drugs were used.
Who cannot join
- Patients with severe liver, kidney, heart and other important organ failure.
- Merger with other autoimmune diseases.
- Amiodarone, iodine contrast agent and other drugs affecting thyroid function are used.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University international hospital
Beijing, Beijing Municipality, 102206
jun zhao, +8601069006708, zhaojun@pkuih.edu.cn
About this study
Autoimmune thyroid disease (AITD) is the main cause of hypothyroidism in reproduction women, iodine and bisphenol A are the environmental factors for AITD. The research was mainly designed to investigate the effect of iodine and BPA on AITD in reproduction women to provide new evidence for hypothyroidism in reproduction women.
Read the detailed description
71 patients with thyroid autoantibody positive were treated as AITD group, another 71 healthy reproduction women were selected as normal group. Women age, BMI, thyroid disease history, family history, marital and reproductive history, whether the application of iodized salt, thyroid function and thyroid autoantibodies detection were recorded. Meanwhile urine iodine, urinary iodine/urinary creatinine, urine BPA and urinary BPA/creatinine were tested. The urine iodine and BPA levels of the two groups were compared. Taking AITD as the dependent variable, logistic regression was conducted to analyze whether urinary iodine and BPA were risk factors of AITD.
- Being tested
- urinary iodine and urine BPA
- Keywords
- iodine, bisphenol A, autoimmune thyroid disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary iodine and urine BPAOther
urinary iodine and urine BPA
| Study group | Role | What they receive |
|---|---|---|
| AITD group | Thyroid antibody positive and hypothyroidism Receives: Other: urinary iodine and urine BPA | |
| normal group | Thyroid antibody negative and hypothyroidism Receives: Other: urinary iodine and urine BPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of urinary iodine levels between the two groups
Urinary iodine levels were compared between patients with autoimmune thyroid disease and normal women.
Measured: 2019-2011
Comparison of urinary BPA levels between the two groups
Urinary BPA levels were compared between patients with autoimmune thyroid disease and normal women.
Measured: 2019-2011
Secondary outcomes (1)
Influencing factors of autoimmune thyroid diseases.
Abnormal levels of iodine and PBA are influential factors in autoimmune thyroid disease.
Measured: 2019-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start24 Jun 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effect of Iodine and BPA on AITD in Reproduction WomenStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaomei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaomei Zhang, Peking University International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932487
- Sponsor's protocol ID
- Peking UIH
- Status last verified
- Mar 2020
- First submitted
- 24 Apr 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Urinary iodine and bisphenol A may affect AITD in reproduction women.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women
- ClinicalTrials.gov ID
- NCT03932487
- Acronym / sponsor ID
- Peking UIH
- Keywords
- iodine, bisphenol A, autoimmune thyroid disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Xiaomei ZhangUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 30 Apr 2019 (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.
Autoimmune thyroid disease (AITD) is the main cause of hypothyroidism in reproduction women, iodine and bisphenol A are the environmental factors for AITD. The research was mainly designed to investigate the effect of iodine and BPA on AITD in reproduction women to provide new evidence for hypothyroidism in reproduction women.
Detailed description
71 patients with thyroid autoantibody positive were treated as AITD group, another 71 healthy reproduction women were selected as normal group. Women age, BMI, thyroid disease history, family history, marital and reproductive history, whether the application of iodized salt, thyroid function and thyroid autoantibodies detection were recorded. Meanwhile urine iodine, urinary iodine/urinary creatinine, urine BPA and urinary BPA/creatinine were tested. The urine iodine and BPA levels of the two groups were compared. Taking AITD as the dependent variable, logistic regression was conducted to analyze whether urinary iodine and BPA were risk factors of AITD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AITD group | – | Other: urinary iodine and urine BPAThyroid antibody positive and hypothyroidism |
| normal group | – | Other: urinary iodine and urine BPAThyroid antibody negative and hypothyroidism |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In Peking University international hospital women of childbearing age (age 20 to 45 years old) of 142 cases of 71 patients with thyroid autoantibodies positive as AITD group, the other selected 71 cases of healthy women of childbearing age as normal group, record the age, BMI, and examination of the history of history of thyroid disease, family history and whether the application of iodized salt and other general information and we, thyroid autoantibodies detection results, urine iodine, urinary iodine/urinary creatinine and urinary BPA and urinary BPA/creatinine detection.
Key inclusion criteria (3 listed)
- AITD group: positive thyroid autoantibody (one thyroid autoantibody), normal thyroid function.
- Normal group: thyroid autoantibody negative, normal thyroid function.
- No previous history of hyperthyroidism or hypothyroidism, no history of thyroid surgery or I131 radiotherapy, and no thyroid hormone or anti-thyroid drugs were used.
Key exclusion criteria (3 listed)
- Patients with severe liver, kidney, heart and other important organ failure.
- Merger with other autoimmune diseases.
- Amiodarone, iodine contrast agent and other drugs affecting thyroid function are used.
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 |
|---|---|---|
| urinary iodine and urine BPAurinary iodine and urine BPA | Other | AITD group, normal group |
Primary outcome
Comparison of urinary iodine levels between the two groups
Time frame: 2019-2011
Urinary iodine levels were compared between patients with autoimmune thyroid disease and normal women.
Comparison of urinary BPA levels between the two groups
Time frame: 2019-2011
Urinary BPA levels were compared between patients with autoimmune thyroid disease and normal women.
1 secondary outcome
Influencing factors of autoimmune thyroid diseases.
Time frame: 2019-2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: Undecided. Urinary iodine and bisphenol A may affect AITD in reproduction women.
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.
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 The Effect of Iodine and BPA on AITD in Reproduction Women, run by Xiaomei Zhang at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jun zhao (+8601069007608, zhaojun@pkuih.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of urinary iodine levels between the two groups (time frame: 2019-2011). The study lists 2 primary outcomes in all. 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 6 Mar 2020.