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临床试验/NCT06234982
NCT06234982招募中不适用

Jodkids: a Study of Iodine Intake Among Children Aged 2-10 Years

DTU National Food Institute1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年1月1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
600
试验地点
1
主要终点
Urinary Iodine Excretion

研究概览

简要总结

The overall aim of the study is to monitor the effects of the increased iodine fortification level implemented in 2019 on iodine intake from the diet (incl. dietary supplements) and the excretion of iodine in urine in children aged 2-10 years.

详细描述

All children in Denmark receive iodine fortification through the iodine fortification program of salt, bread, and baked goods. As DANSDA's results demonstrate a risk of increased iodine intake among the youngest children, it is necessary to carry out the study in these age groups, as this can have harmful effects on children's thyroid health as well as neural development. Children are the group in society that most easily exceeds the intake of iodine, whereas many pregnant women still find it difficult to achieve a sufficient intake with the current level of fortification. Through this study, it is possible to detect and deal with a potentially too high intake in children in time. If, on the other hand, the study shows that the children have a satisfactory intake of iodine, the iodine fortification level can potentially be increased, so that the iodine intake is increased in the groups that still have an iodine intake below the recommended level.

The study consists of two sub-studies. The specific objectives of the sub-studies are to:

  • Iodine status (1): Estimate the iodine intake and food sources of iodine among children after the increased iodine fortification and assess whether some children are at risk of an increased iodine intake (2-10 years old).
  • Diet validation (2): Validate the estimated iodine intake based on dietary records against the actual iodine intake measured in spot urines (4-10-year-olds).

A total of 600 participants are recruited, divided into 200 participants in each of three age groups: 1) 2-3 years, 2) 4-6 years and 3) 7-10 years. A short, electronic questionnaire is completed for all participants. In the iodine status study (1), the child's parents/guardians collect one urine spot sample from each participant to measure the population's iodine intake. The diet validation study (2) is carried out in a subsample of 100 participants divided into 50 participants in each of the age groups 2) 4-6 years and 3) 7-10 years. From here, the child's parents/guardian register data for the dietary intake every day for 7 consecutive days and collect one spot urine per day on the same 7 days when the dietary registration takes place.

All examinations are considered harmless.

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
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2-10 years

排除标准

  • Chronic diseases that can influence iodine metabolism (metabolic diseases, kidney or liver diseases or diabetes)
  • Parents/guardians do not have the opportunity to fill in the basic questionnaire or the diet questionnaire electronically

结局指标

主要结局

Urinary Iodine Excretion

时间窗: Baseline

Iodine and creatinine in urine samples

次要结局

  • BMI(Baseline)
  • Socio-demographic background information(Baseline)
  • Iodine intake(Baseline)

研究者

发起方
DTU National Food Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gitte Ravn-Haren

Senior Researcher

Technical University of Denmark

研究点 (1)

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