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

NCT ID: NCT06234982

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet Habit Iodine Deficiency Iodine Toxicity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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2-3 years of age

2-3 years of age

No interventions assigned to this group

4-6 years of age

4-6 years of age

No interventions assigned to this group

7-10 years of age

7-10 years of age

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role collaborator

DTU National Food Institute

OTHER

Sponsor Role lead

Responsible Party

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Gitte Ravn-Haren

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gitte Ravn-Haren, Ph.D

Role: PRINCIPAL_INVESTIGATOR

DTU National Food Institute

Locations

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Technical University of Denmark

Kongens Lyngby, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Gitte Ravn-Haren, Ph.D

Role: CONTACT

[email protected]
93518989 ext. +45

Facility Contacts

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Gitte Ravn-Haren, Ph.D

Role: primary

[email protected]
93518989 ext. +45

Other Identifiers

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DTUNationalFoodInstitute

Identifier Type: -

Identifier Source: org_study_id