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

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.

Study Overview

• Status: Recruiting
• Conditions: Diet Habit; Iodine Deficiency; Iodine Toxicity

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Gitte Ravn-Haren, Ph.D; Phone Number: +45 93518989; Email: girh@food.dtu.dk

Study Locations

• Denmark
  • Copenhagen
    • Kongens Lyngby, Copenhagen, Denmark, 2800
      • Recruiting
      • Technical University of Denmark
      • Contact: Gitte Ravn-Haren, Ph.D; Phone Number: +45 93518989; Email: girh@food.dtu.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of approximately 600 children aged 2-10 years. The sample includes children in nursery, kindergarten and school up until 5th grade.

Description

Inclusion Criteria:

• Children aged 2-10 years

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
2-3 years of age
4-6 years of age
7-10 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Iodine Excretion	Iodine and creatinine in urine samples	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iodine intake	Dietary intake assessed by a 7-day web-based food diary	Baseline
BMI	Weight and height will be combined to report BMI in kg/m^2	Baseline
Socio-demographic background information	Questionnaire about parents' education	Baseline

Collaborators and Investigators

• Sponsor: DTU National Food Institute
• Collaborators: University Hospital Bispebjerg and Frederiksberg
• Investigators: Principal Investigator: Gitte Ravn-Haren, Ph.D, DTU National Food Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DTUNationalFoodInstitute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No