Thyroid FunctionNCT05677581
Longitudinal Study on the Influence of Iodine Nutrition Status on Thyroid Function of Childbearing Age Women During Pregnancy and 6 Weeks Postpartum
An observational study of Thyroid Function and Iodine Nutrition Status, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The goal of this observational study is to provide a reference for formulating individual appropriate iodine intake programs for women during pregnancy and postpartum and improving the monitoring and evaluation system of maternal iodine nutrition status. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid Function, Iodine Nutrition Status
- What is being tested?
- iodine nutrition status
- How many people
- 2,100 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 31 Dec 2024
- 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: maternal and women of childbearing age in Beijing area
Who may be able to join
- primigravida
- no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases before pregnancy
- no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases before pregnancy
- no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases before pregnancy
- 20-40 years old
- no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases
- no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases
- no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases
Who cannot join
- multiple pregnancies and multigravida
- a history of type I or type II diabetes before pregnancy
- a clear history of thyroid diseases before pregnancy
- taking drugs that affect thyroid function and/or blood sugar before or during early pregnancy
- Healthy women of childbearing age:
- a history of type I or type II diabetes
- a clear history of thyroid diseases
- taking drugs that affect thyroid function and/or blood sugar
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital ,Capital Medical University
Beijing
Lei Yang
About this study
The goal of this observational study is to provide a reference for formulating individual appropriate iodine intake programs for women during pregnancy and postpartum and improving the monitoring and evaluation system of maternal iodine nutrition status. The main questions it aims to answer are:
- To analyse the longitudinal changes of urinary iodine, urinary iodine/creatinine ratio, thyroid function and related factors in different periods of early, middle, late pregnancy and 6 weeks postpartum in Beijing area.
- To explore the relationship between iodine nutrition status and the changes of thyroid function and to further clarify the effect of iodine nutrition status on thyroid function of women of childbearing age during pregnancy and postpartum in combination with dietary intake of iodine questionnaire.
Read more
Participants will be detected there thyroid function, the level of median urinary iodine and urinary iodine/creatinine.
Researchers will compare healthy women of childbearing age served as the control group in the same period.
- Conditions
- Thyroid Function, Iodine Nutrition Status
- Being tested
- iodine nutrition status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodine nutrition statusOther
iodine nutrition status
| Study group | Role | What they receive |
|---|---|---|
| pregnancy and lactation period women | Not described Receives: Other: iodine nutrition status | |
| healthy women of childbearing age | Not described Receives: Other: iodine nutrition status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data of pregnant women in the early trimester of pregnancy
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary iodine and urinary iodine/creatinine
Measured: Any day between weeks 8 and 12 of gestation
Data of pregnant women in the middle trimester of pregnancy
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Measured: Any day between weeks 24 and 28 of gestation
Data of pregnant women in the third trimester of pregnancy
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Measured: Any day between weeks 36 of gestation to the day before parturition
Data of postpartum women
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Measured: 6 weeks after parturition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid FunctionStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677581
- Sponsor's protocol ID
- SF2022-2-2029
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2022
- Last updated
- 10 May 2024
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study on the Influence of Iodine Nutrition Status on Thyroid Function of Childbearing Age Women During Pregnancy and 6 Weeks Postpartum
- ClinicalTrials.gov ID
- NCT05677581
- Acronym / sponsor ID
- SF2022-2-2029
- Conditions
- Thyroid Function, Iodine Nutrition Status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2023 (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.
The goal of this observational study is to provide a reference for formulating individual appropriate iodine intake programs for women during pregnancy and postpartum and improving the monitoring and evaluation system of maternal iodine nutrition status. The main questions it aims to answer are:
- To analyse the longitudinal changes of urinary iodine, urinary iodine/creatinine ratio, thyroid function and related factors in different periods of early, middle, late pregnancy and 6 weeks postpartum in Beijing area.
- To explore the relationship between iodine nutrition status and the changes of thyroid function and to further clarify the effect of iodine nutrition status on thyroid function of women of childbearing age during pregnancy and postpartum in combination with dietary intake of iodine questionnaire.
Participants will be detected there thyroid function, the level of median urinary iodine and urinary iodine/creatinine.
Researchers will compare healthy women of childbearing age served as the control group in the same period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnancy and lactation period women | – | Other: iodine nutrition status |
| healthy women of childbearing age | – | Other: iodine nutrition status |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- maternal and women of childbearing age in Beijing area
Key inclusion criteria (8 listed)
- primigravida
- no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases before pregnancy
- no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases before pregnancy
- no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases before pregnancy
- 20-40 years old
Key exclusion criteria (8 listed)
- multiple pregnancies and multigravida
- a history of type I or type II diabetes before pregnancy
- a clear history of thyroid diseases before pregnancy
- taking drugs that affect thyroid function and/or blood sugar before or during early pregnancy
- a history of type I or type II diabetes
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 |
|---|---|---|
| iodine nutrition statusiodine nutrition status | Other | healthy women of childbearing age, pregnancy and lactation period women |
Primary outcome
Data of pregnant women in the early trimester of pregnancy
Time frame: Any day between weeks 8 and 12 of gestation
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary iodine and urinary iodine/creatinine
Data of pregnant women in the middle trimester of pregnancy
Time frame: Any day between weeks 24 and 28 of gestation
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Data of pregnant women in the third trimester of pregnancy
Time frame: Any day between weeks 36 of gestation to the day before parturition
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Data of postpartum women
Time frame: 6 weeks after parturition
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Function and Iodine Nutrition Status, run by Beijing Friendship Hospital at 1 site in China.
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 8 inclusion and 8 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Yan Long, Chief Physician/Professor (13671148911, longyan_doc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data of pregnant women in the early trimester of pregnancy (time frame: Any day between weeks 8 and 12 of gestation). The study lists 4 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 10 May 2024.