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NCT Number: NCT04419103

Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children

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few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

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Key information

Conditions

Nutritional Requirements

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Institute for Endemic Disease Control and Research

Dezhou, Shandong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Natural exposure of iodine.

Primary outcomes

  1. urinary iodine concentration

    Time frame: 2 weeks

    μg/L

  2. free triiodothyronine

    Time frame: 2 weeks

    pmol/L

  3. water iodine intake

    Time frame: 2 weeks

    μg/day

  4. diet iodine intake

    Time frame: 2 weeks

    μg/day

  5. salt iodine concentration

    Time frame: 2 weeks

    μg/L

  6. free thyroxine

    Time frame: 2 weeks

    pmol/L

  7. thyroid-stimulating hormone

    Time frame: 2 weeks

    mIU/L

  8. thyroperoxidase antibody

    Time frame: 2 weeks

    IU/mL

  9. thyroglobulin antibody

    Time frame: 2 weeks

    IU/mL

  10. urinary iodine excretion

    Time frame: 2 weeks

    μg/day

  11. fecal iodine excretion

    Time frame: 2 weeks

    μg/day

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Collaborators

  • Shandong Institute for Endemic Disease Control and Research

Registry information

Official study title

Study on Physiologic Requirement and Dietary Recommended Nutrient

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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