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The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women

  • Clinicaltrials.gov identifier

    NCT03932487

  • Recruitment Status

    Recruiting

  • First Posted

    April 30, 2019

  • Last update posted

    March 6, 2020

Study Description

Brief 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 reproduction women.

  • Condition or Disease:The Effect of Iodine and BPA on AITD in Reproduction Women
  • Intervention/Treatment: Other: urinary iodine and urine BPA
  • Phase: N/A

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

  • Study Type: Observational
  • Estimated Enrollment: 142 participants
  • Observational Model: Other
  • Time Perspective: Cross-Sectional
  • Official Title: The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: October 2022
  • Estimated Study Completion Date: October 2022

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: AITD group
Thyroid antibody positive and hypothyroidism
Other: urinary iodine and urine BPA
urinary iodine and urine BPA
: normal group
Thyroid antibody negative and hypothyroidism
Other: urinary iodine and urine BPA
urinary iodine and urine BPA

Outcome Measures

  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • Secondary Outcome Measures: 1. Influencing factors of autoimmune thyroid diseases. [ Time Frame: 2019-2012 ]
    Abnormal levels of iodine and PBA are influential factors in autoimmune thyroid disease.

Eligibility Criteria

  • Ages Eligible for Study: 20 to 45 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
  • 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.

Criteria

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.

Contacts and Locations

Contacts

Contact: jun zhao +8601069007608 zhaojun@pkuih.edu.cn

Locations

China, Beijing
Peking University international hospital
Beijing

Sponsors and Collaborators

Xiaomei Zhang

More Information

  • Responsible Party: Xiaomei Zhang
  • ClinicalTrials.gov Identifier: NCT03932487 History of Changes
  • Other Study ID Numbers: Peking UIH
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: March 6, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Plan Description: Urinary iodine and bisphenol A may affect AITD in reproduction women.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Xiaomei Zhang: iodine
    autoimmune thyroid disease
    bisphenol A
  • Additional relevant MeSH terms: Thyroid Diseases