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

Nutritional Requirements Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074770
• Other study ID #: NSFC-8227121511
• Status: Recruiting
• Start date: May 5, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Tianjin Medical University
• Contact: wen Chen, Master
• Phone: 022-83336610
• Email: wenchen[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2650
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Requirements

Intervention

Other:
• no intervention
Natural exposure of iodine

Locations

Country	Name	City	State
China	Shandong Institute for Endemic Disease Control and Research	Yuncheng	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Chen Wen	Shandong Institute for Endemic Disease Control and Research

Country where clinical trial is conducted

China, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary iodine concentration	µg/L	2 weeks
Primary	diet iodine intake	µg/day	2 weeks
Primary	urinary iodine excretion	µg/day	2 weeks
Primary	thyroglobulin antibody	IU/mL	2 weeks
Primary	salt iodine concentration	µg/L	2 weeks
Primary	water iodine intake	µg/day	2 weeks
Primary	thyroid volume	ml	2 weeks