Iodine DeficiencyEUthyroid2NCT06801691
The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
A study testing Experimental: Intervention group in people with Iodine Deficiency, run by EUthyroid at 6 sites in 6 countries.
Trial summary
In the EUthyroid2 intervention, measures are being developed and implemented in educational settings across the UK, Germany, Slovenia, the Republic of Cyprus, Bangladesh, and Pakistan to effectively raise awareness of the risks associated with iodine deficiency. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- What is being tested?
- Experimental: Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 30 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- sufficient language skills to understand the study information, informed consent
Who cannot join
- none
Trial locations and contacts
6 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 6 countries
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh University of Health
Dhaka, 1216
Mithila Faruque, Dr, +880 1791-042087, mithilafaruque@buhs.ac.bd
Cyprus1 site, 1 recruiting
- Recruiting
Cyprus University of Technology
Limassol, 3041
Konstantinos C. Makris, PhD, +357 25002398, konstantinos.makris@cut.ac.cy
Germany1 site, 1 recruiting
- Recruiting
University Medicine Greifswald
Greifswald, 17475
Henry Völzke, Prof. Dr. med., 0049 3834 86 75 41, euthyroid2@uni-greifswald.de
Pakistan1 site, 1 recruiting
- Recruiting
Islamia College Peshawar
Peshawar, Khyber Pakhtunkhwa
Rehman Mehmood Khattak, Dr., +92 91 9222227, rehman.mehmood@icp.edu.pk
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Simona Gaberšček, MD, +38 615 223 551, simona.gaberscek@kclj.si
United Kingdom1 site, 1 recruiting
- Recruiting
University of Surrey; Queen's University Belfast
Guildford, GU2 7XH
Sarah Bath, PhD, RD, FHEA, +44 1483 300800, s.bath@surrey.ac.uk
About this study
In the EUthyroid2 intervention, measures are being developed and implemented in educational settings across the UK, Germany, Slovenia, the Republic of Cyprus, Bangladesh, and Pakistan to effectively raise awareness of the risks associated with iodine deficiency. Each participating country will employ three measurement points. The intervention will be tailored to the specific contextual characteristics of each implementation site. A process evaluation utilizing a convergent parallel mixed methods design will be conducted, involving surveys of students and teachers, as well as semi-structured interviews.
Read the detailed description
Detailed Description:
BACKGROUND: Iodine deficiency (ID) is a leading risk factor for thyroid disorders and developmental impairments in offspring. It is recognized as one of the most preventable causes of mental impairment in children. The EUthyroid2 project aims to contribute to the prevention of ID and its associated symptoms and disease burden in adolescents across Europe and beyond.
AIM: This project seeks to develop and implement an educational intervention in various educational settings, effectively raising awareness of the risks associated with iodine deficiency.
METHODS: The intervention will be conducted in each participating country, with three clusters (secondary schools, high schools, and vocational schools) per country. The goal is to achieve a final sample of 4500 study participants in all countries combined, involving one baseline measurement and two follow-up assessments (2-4 weeks and 6-8 months post-intervention). Data will be collected at all measurement points, with variations in implementation accounted for due to differences between countries. To ensure the intervention's functionality and effectiveness, the project will consider recommendations for developing complex interventions, appropriate theoretical frameworks, and conduct a context analysis. Outcome measures will include a newly developed iodine awareness questionnaire (primary outcome) and an iodine-specific food frequency questionnaire. Additionally, socio-demographic characteristics will be measured. Descriptive analyses will be performed on all variables, with subgroup and country-specific analyses computed. A process evaluation will assess the implementation process using a convergent parallel mixed methods design, inviting teachers and students to participate in an online questionnaire. Semi-structured interviews will further enrich this evaluation.
CONCLUSION/OUTLOOK: The results of the EUthyroid2 project may assist health authorities across participating countries in implementing effective strategies to reduce iodine deficiency and its associated risks. Ultimately, this could lead to a sustainable decrease in the disease burden induced by iodine deficiency.
- Conditions
- Iodine Deficiency
- Being tested
- Experimental: Intervention group
- Keywords
- Prevention, Iodine Deficiency, Intervention Study, Complex Intervention, Adaptation to context, Awareness, Iodine intake, Nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention groupOther
Educational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage This is a pre/post intervention with no control group.
| Study group | Role | What they receive |
|---|---|---|
| Teaching programme on iodine | Experimental | Educational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage Receives: Other: Experimental: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in awareness
- Change in awareness of iodine and iodine deficiency: Difference in iodine awareness is measured by an iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.
Measured: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)
Secondary outcomes (4)
Changes between teaching modalities
Differences in iodine awareness between students taught module A vs module A+B vs module A+C vs module A+B+C. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.
Measured: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Changes in vocational schools, high- and secondary schools
Differences in iodine awareness between students in vocational schools vs high schools vs secondary schools. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.
Measured: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Change between age groups and gender distinctions
Differences in iodine awareness between girls vs boys. Changes in iodine awareness are assessed by the iodine awareness questionnaire.
Differences in iodine awareness between 13-year-olds vs 14-year-olds vs 15-year-olds vs 16-year-olds vs 17-year-olds. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.
Gender and age will be self-reported in a socio-demographic questionnaire.
Measured: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Change in iodine intake
Dietary iodine intake is assessed through a food frequency questionnaire (FFQ), covering five main categories (cow's milk, fish, eggs, supplements, and salt) and regional components in each country. Each category is scored based on frequency (portions per day, week, or month), and individual sources are analyzed for iodine intake. For example, taking supplements 5-7 times a week or consuming a combination of multiple sources of cow's milk, fish and eggs a week may suggest sufficient intake. Regional differences are also considered, as salt is an iodine source in countries like Pakistan and Bangladesh, but not in the UK or Norway. The number of iodine sources will be compared before and after the intervention within each country, with a higher number of sources indicating a higher iodine intake). The number will differ according to the number of sources in each country.
Measured: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start30 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EUthyroid
- Sponsor type
- University, hospital or other
- Collaborators
- EU Horizon, UK Research and Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801691
- Sponsor's protocol ID
- 101095643_2
- Acronym
- EUthyroid2
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
- ClinicalTrials.gov ID
- NCT06801691
- Acronym / sponsor ID
- EUthyroid2 / 101095643_2
- Conditions
- Iodine Deficiency
- Keywords
- Prevention, Iodine Deficiency, Intervention Study, Complex Intervention, Adaptation to context, Awareness, Iodine intake, Nutrition education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- EUthyroidUniversity, hospital or other
- Collaborators
- EU Horizon, UK Research and Innovation
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the EUthyroid2 intervention, measures are being developed and implemented in educational settings across the UK, Germany, Slovenia, the Republic of Cyprus, Bangladesh, and Pakistan to effectively raise awareness of the risks associated with iodine deficiency. Each participating country will employ three measurement points. The intervention will be tailored to the specific contextual characteristics of each implementation site. A process evaluation utilizing a convergent parallel mixed methods design will be conducted, involving surveys of students and teachers, as well as semi-structured interviews.
Detailed description
Detailed Description:
BACKGROUND: Iodine deficiency (ID) is a leading risk factor for thyroid disorders and developmental impairments in offspring. It is recognized as one of the most preventable causes of mental impairment in children. The EUthyroid2 project aims to contribute to the prevention of ID and its associated symptoms and disease burden in adolescents across Europe and beyond.
AIM: This project seeks to develop and implement an educational intervention in various educational settings, effectively raising awareness of the risks associated with iodine deficiency.
METHODS: The intervention will be conducted in each participating country, with three clusters (secondary schools, high schools, and vocational schools) per country. The goal is to achieve a final sample of 4500 study participants in all countries combined, involving one baseline measurement and two follow-up assessments (2-4 weeks and 6-8 months post-intervention). Data will be collected at all measurement points, with variations in implementation accounted for due to differences between countries. To ensure the intervention's functionality and effectiveness, the project will consider recommendations for developing complex interventions, appropriate theoretical frameworks, and conduct a context analysis. Outcome measures will include a newly developed iodine awareness questionnaire (primary outcome) and an iodine-specific food frequency questionnaire. Additionally, socio-demographic characteristics will be measured. Descriptive analyses will be performed on all variables, with subgroup and country-specific analyses computed. A process evaluation will assess the implementation process using a convergent parallel mixed methods design, inviting teachers and students to participate in an online questionnaire. Semi-structured interviews will further enrich this evaluation.
CONCLUSION/OUTLOOK: The results of the EUthyroid2 project may assist health authorities across participating countries in implementing effective strategies to reduce iodine deficiency and its associated risks. Ultimately, this could lead to a sustainable decrease in the disease burden induced by iodine deficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teaching programme on iodine | Experimental | Other: Experimental: Intervention groupEducational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- sufficient language skills to understand the study information, informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Intervention groupEducational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage This is a pre/post intervention with no control group. | Other | Teaching programme on iodine |
Primary outcome
Change in awareness
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)
1. Change in awareness of iodine and iodine deficiency: Difference in iodine awareness is measured by an iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.
4 secondary outcomes
Changes between teaching modalities
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Changes in vocational schools, high- and secondary schools
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Change between age groups and gender distinctions
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Change in iodine intake
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention group in people with Iodine Deficiency, run by EUthyroid at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bangladesh, Cyprus, Germany, Pakistan, Slovenia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry Völzke (0049 3834 86 75 41, henry.voelzke@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in awareness (time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.