跳至主要内容
临床试验/NCT04419103
NCT04419103已完成不适用

Study on Physiologic Requirement and Dietary Recommended Nutrient

Tianjin Medical University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
thyroid-stimulating hormone

研究概览

简要总结

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few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

详细描述

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.

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
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

thyroid-stimulating hormone

时间窗: 2 weeks

mIU/L

thyroperoxidase antibody

时间窗: 2 weeks

IU/mL

thyroglobulin antibody

时间窗: 2 weeks

IU/mL

urinary iodine concentration

时间窗: 2 weeks

μg/L

free triiodothyronine

时间窗: 2 weeks

pmol/L

diet iodine intake

时间窗: 2 weeks

μg/day

salt iodine concentration

时间窗: 2 weeks

μg/L

water iodine intake

时间窗: 2 weeks

μg/day

fecal iodine excretion

时间窗: 2 weeks

μg/day

free thyroxine

时间窗: 2 weeks

pmol/L

urinary iodine excretion

时间窗: 2 weeks

μg/day

次要结局

未报告次要终点

研究者

发起方
Tianjin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Wen

Teacher

Tianjin Medical University

研究点 (1)

Loading locations...

相似试验