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

November 29, 2018 updated by: Rongrong Li

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
risk of thyroid disease
Time Frame: 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)
From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
pregnancy outcomes
Time Frame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
prevalence of other pregnant complications
Time Frame: 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.
From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
prevalence of thyroid disease in neonates
Time Frame: 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
From date of birth to 4 weeks after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rongrong Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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