- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03932487
The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women
March 4, 2020 updated by: Xiaomei Zhang
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
142
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 102206
- Recruiting
- Peking University International Hospital
-
Contact:
- jun zhao
- Phone Number: +8601069006708
- Email: zhaojun@pkuih.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AITD group
Thyroid antibody positive and hypothyroidism
|
urinary iodine and urine BPA
|
|
normal group
Thyroid antibody negative and hypothyroidism
|
urinary iodine and urine BPA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2019-2011
|
|
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.
|
2019-2011
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Influencing factors of autoimmune thyroid diseases.
Time Frame: 2019-2012
|
Abnormal levels of iodine and PBA are influential factors in autoimmune thyroid disease.
|
2019-2012
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 24, 2019
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
April 29, 2019
First Posted (Actual)
April 30, 2019
Study Record Updates
Last Update Posted (Actual)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Peking UIH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Urinary iodine and bisphenol A may affect AITD in reproduction women.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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