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

NCT06074770 | Recruiting

• 1 other identifier: NSFC-8227121511
• Study Type: observational
• Target: 2,650
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Requirements

Keywords

nutrient; dietary intake levels; pre-school children; iodine

Outcome Measures

Primary Outcomes (7)

• urinary iodine concentration

  μg/L

  2 weeks

• diet iodine intake

  μg/day

  2 weeks

• urinary iodine excretion

  μg/day

  2 weeks

• thyroglobulin antibody

  IU/mL

  2 weeks

• salt iodine concentration

  μg/L

  2 weeks

• water iodine intake

  μg/day

  2 weeks

• thyroid volume

  ml

  2 weeks

Interventions

no intervention OTHER

Natural exposure of iodine

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

3-6 years old pre-school children are the research subjects. They were recruited in Tianjin and Shandong.

You may qualify if:

• 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;

You may not qualify if:

• long-term low-protein; long-term low-heat energy malnutrition

Sponsors & Collaborators

• Chen Wen: lead
• Shandong Institute for Endemic Disease Control and Research: collaborator

Study Sites (1)

Shandong Institute for Endemic Disease Control and Research

Yuncheng, Shandong, China

RECRUITING

Related Publications (29)

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  PMID: 23746772 BACKGROUND

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• DU Y, Gao YH, Feng ZY, Meng FG, Fan LJ, Sun DJ. Serum Thyroglobulin-A Sensitive Biomarker of Iodine Nutrition Status and Affected by Thyroid Abnormalities and Disease in Adult Populations. Biomed Environ Sci. 2017 Jul;30(7):508-516. doi: 10.3967/bes2017.067.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

1. A 7-day iodine balance experiment was conducted in pre-school age children with insufficient iodine nutrition. Dietary intervention with different iodine intake, daily food and drinking iodine intake was accurately measured by double meal method, and 24-h urine and feces were collected for the measurement of iodine excretion 2. The epidemiological survey of preschool children aged 3-6 years was carried out in high water iodine areas of Shandong Province, the iodine intake was accurately assessed through dietary survey and 24-h urine samples, and the thyroid volume, thyroglobulin and growth and development were measured to evaluate the effect of long-term high iodine exposure on preschool children

Study Officials

• xiao ming Wang

  Shandong Institute for Endemic Disease Control and Research

  STUDY CHAIR

• dong An

  Tianjin Children's Hospital

  STUDY CHAIR

• fang Fang

  Tianjin Medical University

  STUDY CHAIR

• na Sai

  Tianjin Medical University

  STUDY CHAIR

Central Study Contacts

wen Chen, Master

CONTACT

022-83336610; wenchen@tmu.edu.cn

ying ye

CONTACT

022-83336717; yeying@tmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: May 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)