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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932487
• Other study ID #: Peking UIH
• Status: Recruiting
• Start date: June 24, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2020
• Source: Peking University International Hospital
• Contact: jun zhao
• Phone: +8601069007608
• Email: zhaojun[@]pkuih.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• The Effect of Iodine and BPA on AITD in Reproduction Women
• Thyroid Diseases

Intervention

Other:
• urinary iodine and urine BPA
urinary iodine and urine BPA

Locations

Country	Name	City	State
China	Peking University international hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiaomei Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of urinary iodine levels between the two groups	Urinary iodine levels were compared between patients with autoimmune thyroid disease and normal women.	2019-2011
Primary	Comparison of urinary BPA levels between the two groups	Urinary BPA levels were compared between patients with autoimmune thyroid disease and normal women.	2019-2011
Secondary	Influencing factors of autoimmune thyroid diseases.	Abnormal levels of iodine and PBA are influential factors in autoimmune thyroid disease.	2019-2012