NCT06234982

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 4, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 23, 2024

Last Update Submit

December 2, 2024

Conditions

Diet HabitIodine DeficiencyIodine Toxicity

Outcome Measures

Primary Outcomes (1)

  • Urinary Iodine Excretion

    Iodine and creatinine in urine samples

    Baseline

Secondary Outcomes (3)

  • Iodine intake

    Baseline

  • BMI

    Baseline

  • Socio-demographic background information

    Baseline

Study Arms (3)

2-3 years of age

2-3 years of age

4-6 years of age

4-6 years of age

7-10 years of age

7-10 years of age

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Children aged 2-10 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Denmark

Kongens Lyngby, Copenhagen, 2800, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Samples

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Gitte Ravn-Haren, Ph.D

    DTU National Food Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte Ravn-Haren, Ph.D

CONTACT

93518989girh@food.dtu.dk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

January 23, 2024

First Posted

January 31, 2024

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 4, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)