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

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ClinicalTrials.gov Identifier: NCT03932487
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaomei Zhang, Peking University International Hospital

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 Intervention/treatment
The Effect of Iodine and BPA on AITD in Reproduction Women Other: urinary iodine and urine BPA

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.

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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
Estimated Study Start Date : April 24, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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




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 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 ]
    Taking autoimmune thyroid disease as the dependent variable, to explore whether iodine and PBA are the influencing factors of autoimmune thyroid disease.



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Ages Eligible for Study:   20 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932487


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

Locations
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China, Beijing
Peking University international hospital Recruiting
Beijing, Beijing, China, 102206
Contact: jun zhao    +8601069006708    zhaojun@pkuih.edu.cn   
Sponsors and Collaborators
Xiaomei Zhang

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Responsible Party: Xiaomei Zhang, Director, Head of endocrinology department., Peking University International Hospital
ClinicalTrials.gov Identifier: NCT03932487     History of Changes
Other Study ID Numbers: Peking UIH
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Urinary iodine and bisphenol A may affect AITD in reproduction women.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaomei Zhang, Peking University International Hospital:
iodine
bisphenol A
autoimmune thyroid disease

Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases
Iodine
Cadexomer iodine
Bisphenol A
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents