Longitudinal Study on the Influence of Iodine Nutrition S... | NCT05677581

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Nov 30, 2022

First Submission Date that Met QC Criteria

Dec 28, 2022

First Posted Date

Jan 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2024

Last Update Posted Date

May 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pregnancy and lactation period women			Other: iodine nutrition status
healthy women of childbearing age			Other: iodine nutrition status

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iodine nutrition status	Other	iodine nutrition status	healthy women of childbearing age pregnancy and lactation period women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	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	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	6 weeks after parturition

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

8-12 weeks healthy maternal:

Inclusion Criteria:

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

Exclusion Criteria:

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:

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

maternal and women of childbearing age in Beijing area

Sampling Method

Non-Probability Sample