Clinical trial NCT03932487: The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women
Official title: The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Effect of Iodine and BPA on AITD in Reproduction Women
Keywords: iodine
bisphenol A
autoimmune thyroid disease
Lead sponsor: Peking University International Hospital
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 142
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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.

Primary outcomes:
measure: Comparison of urinary iodine levels between the two groups
timeFrame: 2019-2011
measure: Comparison of urinary BPA levels between the two groups
timeFrame: 2019-2011
Secondary outcomes:
measure: Influencing factors of autoimmune thyroid diseases.
timeFrame: 2019-2012
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University international hospital
state: Beijing
Study officials:
References: