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

NCT ID: NCT03761602

Last Updated: 2018-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Iodine Excess in Pregnancy Selenium Excess in Pregnancy Iodine Deficiency in Pregnancy Selenium Deficiency in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Not applicable (for observational studies)

Intervention Type OTHER

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.

Not applicable (for observational studies)

Intervention Type OTHER

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.

Not applicable (for observational studies)

Intervention Type OTHER

This study is an observational study. No intervention will be administered for research purposes.

Interventions

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Not applicable (for observational studies)

This study is an observational study. No intervention will be administered for research purposes.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rongrong Li

OTHER

Sponsor Role lead

Responsible Party

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Rongrong Li

Nutrition physician

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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ISCMS

Identifier Type: -

Identifier Source: org_study_id

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