The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease
- Conditions
- Iodine Deficiency in PregnancyIodine Excess in PregnancySelenium Excess in PregnancySelenium Deficiency in Pregnancy
- Interventions
- Other: Not applicable (for observational studies)
- Registration Number
- NCT03761602
- Lead Sponsor
- Rongrong Li
- Brief Summary
Two hundred and ninety pregnant women with gestational age less than 20 weeks will be recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be monitored until termination of pregnancy, with pregnancy outcomes recorded.
- Detailed Description
The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and selenium condition will be evaluated through dietary recall (on base of Chinese food ingredient information) and biochemical examinations (serum iodine concentrations, urinary iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine and selenium will be monitored and followed up for all the included subjects throughout the pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be collected. And all the complications (especially thyroid disease) in pregnancy will also be recorded. All pregnant women will be followed up until the termination of pregnancy, with pregnancy outcomes recorded.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 290
- Clinical confirmation of being pregnant.
- Being within less than 20 weeks of gestationa.
- Being pregnant but over 20 weeks of gestationa.
- Mentally or psychologically unstable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Proper selenium and iodine condition Not applicable (for observational studies) The subjects should have proper dietary intake of selenium and iodine, according to Chinese Dietary Reference Intakes (DRIs) (intake of selenium 65μg/d and iodine 230 μg/d). The Serum iodine concentration are 45-92μg/L，and the urinary I/Cr 150-249μg/g Cr. The Serum selenium concentrations are 18-40μg/L. Excessive selenium or iodine condition Not applicable (for observational studies) The subjects have excessive dietary intake of selenium and iodine, usually more than 2 times of DRIs. The Serum iodine concentration are more than 100μg/L，and the urinary I/Cr more than 300μg/g Cr. The Serum selenium concentrations are more than 40μg/L. Insufficient selenium or iodine condition Not applicable (for observational studies) The subjects have insufficient dietary intake of either selenium or iodine, compared with DRIs. The Serum iodine concentration are less than 45μg/L，and the urinary I/Cr less than150μg/g Cr. The Serum selenium concentrations are less than 18μg/L.
- Primary Outcome Measures
Name Time Method pregnancy outcomes From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months prevalence of premature birth, stillbirth and abortion
risk of thyroid disease From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)
- Secondary Outcome Measures
Name Time Method prevalence of other pregnant complications From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months prevalence of gestational diabetes mellitus, gestational hypertension, dyslipidemia, etc.
prevalence of thyroid disease in neonates From date of birth to 4 weeks after birth prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies，or findings of thyroid nodules) in neonates