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临床试验/NCT06074770
NCT06074770招募中不适用

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

Chen Wen1 个研究点 分布在 1 个国家目标入组 2,650 人开始时间: 2023年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,650
试验地点
1
主要终点
urinary iodine concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

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

结局指标

主要结局

urinary iodine concentration

时间窗: 2 weeks

μg/L

salt iodine concentration

时间窗: 2 weeks

μg/L

water iodine intake

时间窗: 2 weeks

μg/day

diet iodine intake

时间窗: 2 weeks

μg/day

urinary iodine excretion

时间窗: 2 weeks

μg/day

thyroid volume

时间窗: 2 weeks

ml

thyroglobulin antibody

时间窗: 2 weeks

IU/mL

次要结局

未报告次要终点

研究者

发起方
Chen Wen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chen Wen

associate professor

Tianjin Medical University

研究点 (1)

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