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

• Conditions: The Effect of Iodine and BPA on AITD in Reproduction Women
• Interventions: Other: urinary iodine and urine BPA

• Registration Number: NCT03932487
• Lead Sponsor: Xiaomei Zhang

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.

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 Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-04-30
• Study Start: 2019-06-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 142

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AITD group	urinary iodine and urine BPA	Thyroid antibody positive and hypothyroidism
normal group	urinary iodine and urine BPA	Thyroid antibody negative and hypothyroidism

Primary Outcome Measures

Name	Time	Method
Comparison of urinary BPA levels between the two groups	2019-2011	Urinary BPA levels were compared between patients with autoimmune thyroid disease and normal women.
Comparison of urinary iodine levels between the two groups	2019-2011	Urinary iodine levels were compared between patients with autoimmune thyroid disease and normal women.

Secondary Outcome Measures

Name	Time	Method
Influencing factors of autoimmune thyroid diseases.	2019-2012	Abnormal levels of iodine and PBA are influential factors in autoimmune thyroid disease.

Trial Locations

Locations (1)

Peking University international hospital; 🇨🇳 Beijing, Beijing, China