Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children

November 22, 2022 updated by: Chen Wen, Tianjin Medical University

Study on Physiologic Requirement and Dietary Recommended Nutrient

Iodine is one of essential micronutrient for human, both iodine deficiency and excess will be harmful for human health. Children is the susceptible population to iodine nutrition, and studies show that even mild iodine deficiency would affect the growth and development of children, so it is urgent to identify the dietary recommended nutrient intake (RNI) of iodine for children to guide children scientifically and safely supplement iodine. There are few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Based on the investigators'previous study on upper safe level of iodine on children from areas with high iodine in drinking water, this study will conduct an epidemiological study on 600 children living in areas with high water iodine content but the actual iodine content in participants' drinking water is not so high, while no supply of iodized salt.

Meanwhile, in order to get iodine dietary recommended nutrient intake (RNI) values of children. The investigators will conduct a iodine balance experiment on children with sufficient iodine nutrition. We will randomly select thirty healthy students for a three-day iodine balance experiment from the cross-sectional study. The investigators will use the regression model to obtain an iodine intake value when children at"zero iodine"balance. Combine the study at population and individual level, the investigators will obtain data on dietary recommended nutrient intake (RNI) of iodine for Chinese children, to properly guide children iodine supplementation to avoid iodine deficiency, which also will provide data for the update of Chinese dietary reference intakes of iodine.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

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

Study Locations

  • China
    • Shandong
      • Dezhou, Shandong, China
        • Shandong Institute for Endemic Disease Control and Research

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

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

7-11 years old Primary school students who in grades 2, 3, 4 and 5 are the research subjects.They were recruited in Shandong.

Description

Inclusion Criteria:

Normal body mass index and thyroid function have not been treated for thyroid disease have not used amiodarone and other drugs (including iodine supplements) during the investigation have no major diseases and family history have lived in the local area for more than 5 years

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
free triiodothyronine
Time Frame: 2 weeks
pmol/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
free thyroxine
Time Frame: 2 weeks
pmol/L
2 weeks
thyroid-stimulating hormone
Time Frame: 2 weeks
mIU/L
2 weeks
thyroperoxidase antibody
Time Frame: 2 weeks
IU/mL
2 weeks
thyroglobulin antibody
Time Frame: 2 weeks
IU/mL
2 weeks
urinary iodine excretion
Time Frame: 2 weeks
μg/day
2 weeks
fecal iodine excretion
Time Frame: 2 weeks
μg/day
2 weeks

Collaborators and Investigators

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

Sponsor

Tianjin Medical University

Collaborators

Shandong Institute for Endemic Disease Control and Research

Investigators

  • Principal Investigator: xiao ming Wang, Shandong Institute for Endemic Disease Control and Research
  • Principal Investigator: gui jun Tan, The First Central Hospital of Tianjin Medical University
  • Principal Investigator: man Zhang, Shandong Institute for Endemic Disease Control and Research

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)

July 1, 2019

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NSFC-81803223

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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