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Clinical Trials/NCT04419103
NCT04419103CompletedNot Applicable

Study on Physiologic Requirement and Dietary Recommended Nutrient

Tianjin Medical University1 site in 1 country600 target enrollmentStarted: July 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
600
Locations
1
Primary Endpoint
thyroid-stimulating hormone

Study Overview

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few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.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

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
7 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

thyroid-stimulating hormone

Time Frame: 2 weeks

mIU/L

thyroperoxidase antibody

Time Frame: 2 weeks

IU/mL

thyroglobulin antibody

Time Frame: 2 weeks

IU/mL

urinary iodine concentration

Time Frame: 2 weeks

μg/L

free triiodothyronine

Time Frame: 2 weeks

pmol/L

diet iodine intake

Time Frame: 2 weeks

μg/day

salt iodine concentration

Time Frame: 2 weeks

μg/L

water iodine intake

Time Frame: 2 weeks

μg/day

fecal iodine excretion

Time Frame: 2 weeks

μg/day

free thyroxine

Time Frame: 2 weeks

pmol/L

urinary iodine excretion

Time Frame: 2 weeks

μg/day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Tianjin Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chen Wen

Teacher

Tianjin Medical University

Study Sites (1)

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