Clinical trial NCT04419103: Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children
Official title: Study on Physiologic Requirement and Dietary Recommended Nutrient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Requirements
Keywords: nutrient
public nutrition
nutrition related diseases
nutrition epidemiology
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Shandong Institute for Endemic Disease Control and Research
First posted: 2020-06-05
Enrollment: 600
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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are few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

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.

Eligibility criteria: 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

Primary outcomes:
measure: urinary iodine concentration
timeFrame: 2 weeks
measure: free triiodothyronine
timeFrame: 2 weeks
measure: water iodine intake
timeFrame: 2 weeks
measure: diet iodine intake
timeFrame: 2 weeks
measure: salt iodine concentration
timeFrame: 2 weeks
measure: free thyroxine
timeFrame: 2 weeks
measure: thyroid-stimulating hormone
timeFrame: 2 weeks
measure: thyroperoxidase antibody
timeFrame: 2 weeks
measure: thyroglobulin antibody
timeFrame: 2 weeks
measure: urinary iodine excretion
timeFrame: 2 weeks
measure: fecal iodine excretion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dezhou
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: PRINCIPAL_INVESTIGATOR
affiliation: The First Central Hospital of Tianjin Medical University
name: gui jun Tan
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Institute for Endemic Disease Control and Research
name: man Zhang
role: PRINCIPAL_INVESTIGATOR
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