Study on Dietary Intake Levels of Iodine for 3-6 Years Old Pre-school Children

October 5, 2023 updated by: Chen Wen
Iodine as an essential trace element for human, both excessive and insufficient intake would be harmful for human health. As susceptible population, children will be more sensitive to adverse effects caused by inadequate intake of iodine since they are at the peak of growth and development. Meanwhile, there are few direct evidence to establish dietary intakes levels of iodine for 3-6 years old pre-school children.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study plan to conduct iodine balance experiment by providing devised diet consist of different iodine contents, in order to simulate iodine equilibrium of iodine deficiency to iodine excess in children and find the lowest iodine requirement of iodine for pre-school children, then aim to provide data to establish recommend nutrient intake of iodine for 3-6-year-old pre-school children. On the other hand, this study will make use of natural geographic environment with high water iodine in China. The investigators will conduct big-scale epidemiologic study in areas with high water iodine levels in Shandong and areas with adequate iodine in Tianjin, to enroll pre-school children with various iodine intake levels. The investigators will collect 24-hour urine samples as well as dietary records to evaluate iodine intake levels, and detect thyroid volume and thyroglobulin to evaluate the effects of various iodine intake on pre-school children, aiming to find the lowest safe intake level of iodine and then establish the tolerable upper intake level (UL) of iodine for 3-6-year-old pre-school children. This study aims to define the RNI and UL of iodine for 3-6-year-old pre-school children, to provide data for revision of Chinese dietary intake levels of iodine, and to guide children safe and scientifical iodine fortification.

Study Type

Observational

Enrollment (Estimated)

2650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Yuncheng, Shandong, China
        • Recruiting
        • Shandong Institute for Endemic Disease Control and Research
        • Contact:
        • Contact:

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

3-6 years old pre-school children are the research subjects. They were recruited in Tianjin and Shandong.

Description

Inclusion Criteria:

  • for children with mild malnutrition: hemoglobin <110g / L, or weight for age <P50 according to the Chinese 2009 child growth and development reference standard, or BMI z score <-1 according to the WHO Child Growth Assessment Software (version 3.2.2 ) ; have not been treated for thyroid disease; have not used amiodarone and other drugs (including iodine supplements) during the investigation; have no major diseases ,chronic diseases and family history.
  • for children with good nutritional status: healthy,-1 <BMI z score <1; have not been treated for thyroid disease; have not used amiodarone and other drugs (including iodine supplements) during the investigation; have no major diseases ,chronic diseases and family history;

Exclusion Criteria:

long-term low-protein; long-term low-heat energy malnutrition

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary iodine concentration
Time Frame: 2 weeks
μg/L
2 weeks
water iodine intake
Time Frame: 2 weeks
μg/day
2 weeks
diet iodine intake
Time Frame: 2 weeks
μg/day
2 weeks
salt iodine concentration
Time Frame: 2 weeks
μg/L
2 weeks
thyroglobulin antibody
Time Frame: 2 weeks
IU/mL
2 weeks
urinary iodine excretion
Time Frame: 2 weeks
μg/day
2 weeks
thyroid volume
Time Frame: 2 weeks
ml
2 weeks

Collaborators and Investigators

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

Sponsor

Chen Wen

Collaborators

Shandong Institute for Endemic Disease Control and Research

Investigators

  • Study Chair: xiao ming Wang, Shandong Institute for Endemic Disease Control and Research
  • Study Chair: dong An, Tianjin Children's Hospital
  • Study Chair: fang Fang, Tianjin Medical University
  • Study Chair: na Sai, Tianjin Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 5, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NSFC-8227121511

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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