The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease

The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease: a Prospective Registry Study

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.

Study Overview

• Status: Unknown
• Conditions: Iodine Excess in Pregnancy; Selenium Excess in Pregnancy; Iodine Deficiency in Pregnancy; Selenium Deficiency in Pregnancy
• Intervention / Treatment: Other: Not applicable (for observational studies)

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.

• Study Type: Observational
• Enrollment (Anticipated): 290

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Two hundred and ninety pregnant women with gestational age less than 20 weeks should be recruited in this study and will be followed up throughout the whole pregnancy.

Description

Inclusion Criteria:

• Clinical confirmation of being pregnant.
• Being within less than 20 weeks of gestationa.

Exclusion Criteria:

• Being pregnant but over 20 weeks of gestationa.
• Mentally or psychologically unstable.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Proper selenium and iodine condition; 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.	Other: Not applicable (for observational studies); This study is an observational study. No intervention will be administered for research purposes.
Excessive selenium or iodine condition; 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.	Other: Not applicable (for observational studies); This study is an observational study. No intervention will be administered for research purposes.
Insufficient selenium or iodine condition; 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.	Other: Not applicable (for observational studies); This study is an observational study. No intervention will be administered for research purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk of thyroid disease	prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)	From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
pregnancy outcomes	prevalence of premature birth, stillbirth and abortion	From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of other pregnant complications	prevalence of gestational diabetes mellitus, gestational hypertension, dyslipidemia, etc.	From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
prevalence of thyroid disease in neonates	prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies，or findings of thyroid nodules) in neonates	From date of birth to 4 weeks after birth

Collaborators and Investigators

• Sponsor: Rongrong Li

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: ISCMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No