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

• Sponsor: Xiaomei Zhang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03932487
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Anticipated Duration (Months): 39.3
• Patients Per Site Per Month: 3.6

Study Details

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	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Jun 24, 2019
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	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 [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 [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. [2019-2012]

   Abnormal levels of iodine and PBA are influential factors in autoimmune thyroid disease.

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	Peking University international hospital	Beijing	Beijing	China	102206

Sponsors and Collaborators

• Xiaomei Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaomei Zhang, Director, Head of endocrinology department., Peking University International Hospital
• ClinicalTrials.gov Identifier: NCT03932487
• Other Study ID Numbers: Peking UIH
• First Posted: Apr 30, 2019
• Last Update Posted: Mar 6, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaomei Zhang, Director, Head of endocrinology department., Peking University International Hospital: iodine; bisphenol A; autoimmune thyroid disease
• Additional relevant MeSH terms: Thyroid Diseases

Study Results

No Results Posted as of Mar 6, 2020