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NCT Number: NCT06074770

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

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.

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Key information

Conditions

Nutritional Requirements

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

No intervention

Other

Natural exposure of iodine

Primary outcomes

  1. urinary iodine concentration

    Time frame: 2 weeks

    μg/L

  2. diet iodine intake

    Time frame: 2 weeks

    μg/day

  3. urinary iodine excretion

    Time frame: 2 weeks

    μg/day

  4. thyroglobulin antibody

    Time frame: 2 weeks

    IU/mL

  5. salt iodine concentration

    Time frame: 2 weeks

    μg/L

  6. water iodine intake

    Time frame: 2 weeks

    μg/day

  7. thyroid volume

    Time frame: 2 weeks

    ml

Study contacts

Contact information is provided by the study sponsor or research team.

wen Chen, Master

CONTACT

[email protected]

022-83336610

ying ye

CONTACT

[email protected]

022-83336717

Sponsors and collaborators

Lead sponsor

Chen Wen

Other

Collaborators

  • Shandong Institute for Endemic Disease Control and Research

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

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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