Iodine Excess in PregnancyNCT03761602
The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease
An observational study of Iodine Excess in Pregnancy and Selenium Excess in Pregnancy, run by Rongrong Li.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Excess in Pregnancy, Selenium Excess in Pregnancy, Iodine Deficiency in Pregnancy
- What is being tested?
- Not applicable (for observational studies)
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 31 Dec 2019
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical confirmation of being pregnant.
- Being within less than 20 weeks of gestationa.
Who cannot join
- Being pregnant but over 20 weeks of gestationa.
- Mentally or psychologically unstable.
About this study
Official title: 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.
Read the 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.
- Conditions
- Iodine Excess in Pregnancy, Selenium Excess in Pregnancy, Iodine Deficiency in Pregnancy, Selenium Deficiency in Pregnancy
- Being tested
- Not applicable (for observational studies)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable (for observational studies)Other
This study is an observational study. No intervention will be administered for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Not applicable (for observational studies) | |
| 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. Receives: Other: Not applicable (for observational studies) | |
| 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. Receives: Other: Not applicable (for observational studies) |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of thyroid disease
prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)
Measured: 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
Measured: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
Secondary outcomes (2)
prevalence of other pregnant complications
prevalence of gestational diabetes mellitus, gestational hypertension, dyslipidemia, etc.
Measured: 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
Measured: From date of birth to 4 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Dec 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine Excess in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Rongrong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rongrong Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761602
- Sponsor's protocol ID
- ISCMS
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease: a Prospective Registry Study
- ClinicalTrials.gov ID
- NCT03761602
- Acronym / sponsor ID
- ISCMS
- Conditions
- Iodine Excess in Pregnancy, Selenium Excess in Pregnancy, Iodine Deficiency in Pregnancy, Selenium Deficiency in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Rongrong LiUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proper selenium and iodine condition | – | Other: 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 | – | Other: 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 | – | Other: 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical confirmation of being pregnant.
- Being within less than 20 weeks of gestationa.
Key exclusion criteria (2 listed)
- Being pregnant but over 20 weeks of gestationa.
- Mentally or psychologically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable (for observational studies)This study is an observational study. No intervention will be administered for research purposes. | Other | Excessive selenium or iodine condition, Insufficient selenium or iodine condition, Proper selenium and iodine condition |
Primary outcome
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)
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
2 secondary outcomes
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 thyroid disease in neonates
Time frame: From date of birth to 4 weeks after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Excess in Pregnancy and Selenium Excess in Pregnancy, run by Rongrong Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of thyroid disease (time frame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.