Clinical trial NCT06074770: Study on Dietary Intake Levels of Iodine for 3-6 Years Old Pre-school Children
Official title: Study on Dietary Intake Levels of Iodine for 3-6 Years Old Pre-school Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nutritional Requirements
Keywords: nutrient
dietary intake levels
pre-school children
iodine
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Shandong Institute for Endemic Disease Control and Research
First posted: 2023-10-10
Enrollment: 2650
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 3-6 years old pre-school children are the research subjects. They were recruited in Tianjin and Shandong.

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.

Eligibility criteria: 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

Primary outcomes:
measure: urinary iodine concentration
timeFrame: 2 weeks
measure: diet iodine intake
timeFrame: 2 weeks
measure: urinary iodine excretion
timeFrame: 2 weeks
measure: thyroglobulin antibody
timeFrame: 2 weeks
measure: salt iodine concentration
timeFrame: 2 weeks
measure: water iodine intake
timeFrame: 2 weeks
measure: thyroid volume
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yuncheng
country: China
facility: Shandong Institute for Endemic Disease Control and Research
state: Shandong
Study officials:
affiliation: Shandong Institute for Endemic Disease Control and Research
name: xiao ming Wang
role: STUDY_CHAIR
affiliation: Tianjin Children's Hospital
name: dong An
role: STUDY_CHAIR
affiliation: Tianjin Medical University
name: fang Fang
role: STUDY_CHAIR
affiliation: Tianjin Medical University
name: na Sai
role: STUDY_CHAIR
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