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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06074770
Enrollment
2650
Registered
2023-10-10
Start date
2023-05-05
Completion date
2026-12-31
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Requirements

Keywords

nutrient, dietary intake levels, pre-school children, iodine

Brief 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.

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.

Interventions

OTHERno intervention

Natural exposure of iodine

Sponsors

Shandong Institute for Endemic Disease Control and Research
CollaboratorUNKNOWN
Chen Wen
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
urinary iodine concentration2 weeksμg/L
diet iodine intake2 weeksμg/day
urinary iodine excretion2 weeksμg/day
thyroglobulin antibody2 weeksIU/mL
salt iodine concentration2 weeksμg/L
water iodine intake2 weeksμg/day
thyroid volume2 weeksml

Countries

China

Contacts

Primary Contactwen Chen, Master
wenchen@tmu.edu.cn022-83336610
Backup Contactying ye
yeying@tmu.edu.cn022-83336717

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026