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

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:

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:

  1. AITD group: positive thyroid autoantibody (one thyroid autoantibody), normal thyroid function.
  2. Normal group: thyroid autoantibody negative, normal thyroid function.
  3. 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:

  1. Patients with severe liver, kidney, heart and other important organ failure.
  2. Merger with other autoimmune diseases.
  3. 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

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.

Clinical Trials on The Effect of Iodine and BPA on AITD in Reproduction Women

Clinical Trials on urinary iodine and urine BPA

Subscribe