Iodine DeficiencyEUthyroid2NCT06769009
EUthyroid2: the Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
A study testing Educational intervention measures on iodine, iodine deficiency and iodine intake in people with Iodine Deficiency, run by EUthyroid at 6 sites in 5 countries.
Trial summary
In EUthyroid2 intervention measures are to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of iodine deficiency among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- What is being tested?
- Educational intervention measures on iodine, iodine deficiency and iodine intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 18 Nov 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 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-pregnant Female
- Age 18-24 years at the time point of recruitment
- Attending the specified settings
- Sufficient language skills to understand the study information, informed consent and the questionnaire
Who cannot join
- Having a thyroid disease
- Pregnancy at the timepoint of recruitment and during the intervention period
- Lactation
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
The Queen's University of Belfast
Belfast, BT7 1NN
Jayne Woodside, Prof., +44 28 909 78942, j.woodside@qub.ac.uk
- Not yet recruiting
University of Surrey
Guildford, GU2 7XH
Sarah Bath, PhD, RD, FHEA, +44 1483 300800, s.bath@surrey.ac.uk
Bangladesh1 site, 1 recruiting
- Not yet recruiting
Bangladesh University of Health
Dhaka, 1216
Mithila Faruque, Dr., +880 1791-042087, mithilafaruque@buhs.ac.bd
Norway1 site, 1 recruiting
- Recruiting
Institute of Marine Research
Bergen, Bergen, 5817
Lisbeth Dahl, Dr., +47 472 91 689, lisbeth.dahl@hi.no
Pakistan1 site, 1 recruiting
- Not yet recruiting
Islamia College Peshawar
Peshawar, Khyber Pakhtunkhwa
Rehman Mehmood Khattak, Dr., +92 91 9222227, rehman.mehmood@icp.edu.pk
Poland1 site, 1 recruiting
- Not yet recruiting
Jagiellonian University
Krakow, 31-007
Małgorzata Trofimiuk-Müldner, MD PhD, +48 12 4002300, malgorzata.trofimiuk@uj.edu.pl
About this study
Official title: The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
In EUthyroid2 intervention measures are to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of iodine deficiency among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan. A cluster-randomized controlled trial with three points of measurements will be applied in each participating country. The intervention will be adapted to the different contextual characteristics of the implementation sites. A process evaluation with a convergent parallel mixed methods design will be conducted. For this, participants and healthcare professionals will be surveyed and semi-structured interviews will be carried out.
Read the detailed description
BACKGROUND: Iodine deficiency (ID) is a leading risk factor for the development of thyroid disorders, of which in particular women are affected. During pregnancy, ID can increase the risk of developmental disorders in the offspring, however, it is considered as one of the most preventable causes of mental impairment in children. Therefore, the EUthyroid2 project aims to contribute to the prevention of ID and associated symptom and disease burden in adolescence and young women in Europe and beyond.
AIM: An educational intervention is to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of ID among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan.
METHODS: A cluster-randomised controlled trial is to be conducted in each of the five countries. 10 clusters per country (5 intervention group clusters and 5 control group clusters) are planned to achieve a final sample size of 200 study participants per implementing country with one baseline (before the intervention) and two follow-up measurements (2-4 weeks and 6-8 months after the intervention). In all, 1000 participants are to be recruited and data for all measurement points collected. Due to differences in the healthcare systems, the ambulatory care units, where the intervention will be implemented, may vary across the countries. Before recruiting the women, the healthcare professionals who carry out the intervention will receive a specially designed training program. To assure the intervention's functionality and effectiveness, recommendations for the development of complex interventions, appropriate theories and frameworks will be considered and a context analysis will be conducted. The primary outcome of the study is iodine awareness and knowledge measured by a newly developed questionnaire. Other outcomes includes measurement of iodine status (urinary iodine concentration), intake of dietary iodine sources (measured by a food frequency questionnaire), and iodine related behaviours. Sociodemographic characteristics and general dietary habits will also be measured. Descriptive analyses for all variables will be performed. Intervention groups will be compared to control groups over time to test effectiveness. Subgroup and country-specific analyses will also be computed. A process evaluation will be conducted to evaluate the implementation process with a convergent parallel mixed methods design. For this, healthcare professionals in the ambulatory care settings and the women who received the intervention will be invited to participate in an online survey. Further, ca. 20-30 semi-structured interviews will be conducted with women and healthcare professionals.
CONCLUSION / OUTLOOK: The project results may support health authorities across countries to implement effective measures to reduce ID and associated risks. This may sustainably reduce the disease burden induced by ID for young women, pregnant women and their offspring.
- Conditions
- Iodine Deficiency
- Being tested
- Educational intervention measures on iodine, iodine deficiency and iodine intake
- Keywords
- prevention, iodine deficiency, intervention study, cluster-randomized controlled trial, complex intervention, adaption to context, awareness, urinary iodine status, iodine intake, nutrition, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention measures on iodine, iodine deficiency and iodine intakeBehavioural
The intervention consist of an educational intervention which will educate the young women on the importance of iodine, the consequences of iodine deficiency, dietary iodine sources and the iodine in pregnancy. The educational intervention consist of four intervention components: an iodine feedback tool, and educational iodine conversation with a healthcare professional, an iodine factsheet and an iodine video. The healthcare professionals who carry out the educational conversation will receive a specially designed training program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Educational intervention measures on iodine, iodine deficiency and iodine intake |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant change in awareness of iodine in women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) and compared to women (18-24 years) in the control group.
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.
The difference in iodine awareness in women (18-24 years) is examined:
- within the intervention group from:
- T1 (baseline) compared to T2 (2-4 weeks after the intervention)
- T1 (baseline) compared to T3 (6-8 months after the intervention)
- in the intervention compared to the control group at:
- T2 (2-4 weeks after the intervention)
- T3 (6-8 months after the intervention)
Measured: T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)
Secondary outcomes (4)
Significant change in the urinary iodine status of women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) or T3 (6-8 months) and compared to women (18-24 years) in the control group
The urinary iodine concentration will be measured on a scale from 0- to n (there is no maximum value). The median UIC will be compared against the WHO classification of adequate iodine intake of a median UIC ≥100 µg/L and will be compared within the interention group and at each time-point between the intervention and control group.
Difference in iodine status (measured by UIC in µg/L) of women (18-14 years) is examined:
- within the intervention group before and after the intervention:
- T1 (baseline) compared to T2 (2-4 weeks after the intervention)
- T1 (baseline) compared to T3 (6-8 months after the intervention)
- in the intervention group compared to the control group at:
- T2 (2-4 weeks after the intervention)
- T3 (6-8 months after the intervention)
Measured: T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)
Significant change in intake of dietary iodine sources of women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) or T3 (6-8 months) and compared to women (18-24 years) in the control group
Differences in intake of dietary iodine sources is measured by a food frequency questionnaire (FFQ).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.
Difference in the FFQ of women (18-24 years) is examined:
- within the intervention group before and after the intervention:
- T1 (baseline) compared to T2 (2-4 weeks after the intervention)
- T1 (baseline) compared to T3 (6-8 months after the intervention)
- in the intervention group compared to the control group at:
- T2 (2-4 weeks after the intervention)
- T3 (6-8 months after the intervention)
The outcomes will be analyzed statistically based on the different answers in the questionnaire and regional differences.
Measured: T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)
Significant change in awareness of iodine of healthcare professionals before (T1) and after the training (T2)
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.
Difference in iodine awareness of the healthcare professional is examined before and after the training:
- T1 (baseline) compared to T2 (2-4 weeks after the intervention)
Measured: T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)
Significant change in intake of dietary iodine sources of the healthcare professional before (T1) and after the training (T2)
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.
Difference in the FFQ of healthcare professional is compared before and after the training:
- T1 (baseline) compared to T2 (2-4 weeks after the intervention)
Measured: T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start18 Nov 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,000 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
- NCT06769009
- Sponsor's protocol ID
- 101095643
- Acronym
- EUthyroid2
- Status last verified
- Feb 2025
- First submitted
- 21 Nov 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Christensen BJ, Cecon-Stabel N, Sleire SN, Dahl L, Hansen SS, Pendt P, Ittermann T, Khattak MNK, Henck V, Volzke H, Faruque M, Alam F, Khattak RM, Imtiaz A, Khan MA, Soursou G, Makris KC, Gaberscek S, Zaletel K, Studen KB, Woodside JV, Bath SC, Henderson L, Bokor A, De Bock F, Ravn-Haren G. Enhancing iodine health awareness among adolescents: a study protocol for a multi-country intervention study in educational settings across the UK, Slovenia, Cyprus, Bangladesh, Germany and Pakistan. BMC Public Health. 2026 Apr 1;26(1):1531. doi: 10.1186/s12889-026-27121-w.
PubMed 41923016
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 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
- NCT06769009
- Acronym / sponsor ID
- EUthyroid2 / 101095643
- Conditions
- Iodine Deficiency
- Keywords
- prevention, iodine deficiency, intervention study, cluster-randomized controlled trial, complex intervention, adaption to context, awareness, urinary iodine status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- EUthyroidUniversity, hospital or other
- Collaborators
- EU Horizon, UK Research and Innovation
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 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 EUthyroid2 intervention measures are to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of iodine deficiency among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan. A cluster-randomized controlled trial with three points of measurements will be applied in each participating country. The intervention will be adapted to the different contextual characteristics of the implementation sites. A process evaluation with a convergent parallel mixed methods design will be conducted. For this, participants and healthcare professionals will be surveyed and semi-structured interviews will be carried out.
Detailed description
BACKGROUND: Iodine deficiency (ID) is a leading risk factor for the development of thyroid disorders, of which in particular women are affected. During pregnancy, ID can increase the risk of developmental disorders in the offspring, however, it is considered as one of the most preventable causes of mental impairment in children. Therefore, the EUthyroid2 project aims to contribute to the prevention of ID and associated symptom and disease burden in adolescence and young women in Europe and beyond.
AIM: An educational intervention is to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of ID among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan.
METHODS: A cluster-randomised controlled trial is to be conducted in each of the five countries. 10 clusters per country (5 intervention group clusters and 5 control group clusters) are planned to achieve a final sample size of 200 study participants per implementing country with one baseline (before the intervention) and two follow-up measurements (2-4 weeks and 6-8 months after the intervention). In all, 1000 participants are to be recruited and data for all measurement points collected. Due to differences in the healthcare systems, the ambulatory care units, where the intervention will be implemented, may vary across the countries. Before recruiting the women, the healthcare professionals who carry out the intervention will receive a specially designed training program. To assure the intervention's functionality and effectiveness, recommendations for the development of complex interventions, appropriate theories and frameworks will be considered and a context analysis will be conducted. The primary outcome of the study is iodine awareness and knowledge measured by a newly developed questionnaire. Other outcomes includes measurement of iodine status (urinary iodine concentration), intake of dietary iodine sources (measured by a food frequency questionnaire), and iodine related behaviours. Sociodemographic characteristics and general dietary habits will also be measured. Descriptive analyses for all variables will be performed. Intervention groups will be compared to control groups over time to test effectiveness. Subgroup and country-specific analyses will also be computed. A process evaluation will be conducted to evaluate the implementation process with a convergent parallel mixed methods design. For this, healthcare professionals in the ambulatory care settings and the women who received the intervention will be invited to participate in an online survey. Further, ca. 20-30 semi-structured interviews will be conducted with women and healthcare professionals.
CONCLUSION / OUTLOOK: The project results may support health authorities across countries to implement effective measures to reduce ID and associated risks. This may sustainably reduce the disease burden induced by ID for young women, pregnant women and their offspring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Educational intervention measures on iodine, iodine deficiency and iodine intake |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non-pregnant Female
- Age 18-24 years at the time point of recruitment
- Attending the specified settings
- Sufficient language skills to understand the study information, informed consent and the questionnaire
Key exclusion criteria (3 listed)
- Having a thyroid disease
- Pregnancy at the timepoint of recruitment and during the intervention period
- Lactation
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 |
|---|---|---|
| Educational intervention measures on iodine, iodine deficiency and iodine intakeThe intervention consist of an educational intervention which will educate the young women on the importance of iodine, the consequences of iodine deficiency, dietary iodine sources and the iodine in pregnancy. The educational intervention consist of four intervention components: an iodine feedback tool, and educational iodine conversation with a healthcare professional, an iodine factsheet and an iodine video. The healthcare professionals who carry out the educational conversation will receive a specially designed training program. | Behavioural | Intervention Group |
Primary outcome
Significant change in awareness of iodine in women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) and compared to women (18-24 years) in the control group.
Time frame: T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)
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. The difference in iodine awareness in women (18-24 years) is examined: 1. within the intervention group from: * T1 (baseline) compared to T2 (2-4 weeks after the intervention) * T1 (baseline) compared to T3 (6-8 months after the intervention) 2. in the intervention compared to the control group at: * T2 (2-4 weeks after the intervention) * T3 (6-8 months after the intervention)
4 secondary outcomes
Significant change in the urinary iodine status of women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) or T3 (6-8 months) and compared to women (18-24 years) in the control group
Time frame: T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)
Significant change in intake of dietary iodine sources of women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) or T3 (6-8 months) and compared to women (18-24 years) in the control group
Time frame: T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)
Significant change in awareness of iodine of healthcare professionals before (T1) and after the training (T2)
Time frame: T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)
Significant change in intake of dietary iodine sources of the healthcare professional before (T1) and after the training (T2)
Time frame: T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)
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 5 Feb 2025.
- Derived from this study: PubMed 41923016Christensen BJ, Cecon-Stabel N, Sleire SN, Dahl L, Hansen SS, Pendt P, Ittermann T, Khattak MNK, Henck V, Volzke H, Faruque M, Alam F, Khattak RM, Imtiaz A, Khan MA, Soursou G, Makris KC, Gaberscek S, Zaletel K, Studen KB, Woodside JV, Bath SC, Henderson L, Bokor A, De Bock F, Ravn-Haren G. Enhancing iodine health awareness among adolescents: a study protocol for a multi-country intervention study in educational settings across the UK, Slovenia, Cyprus, Bangladesh, Germany and Pakistan. BMC Public Health. 2026 Apr 1;26(1):1531. doi: 10.1186/s12889-026-27121-w.
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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 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention measures on iodine, iodine deficiency and iodine intake in people with Iodine Deficiency, run by EUthyroid at 6 sites in 5 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 4 inclusion and 3 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 5 Feb 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 United Kingdom, Bangladesh, Norway, Pakistan, Poland. 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, euthyroid2@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant change in awareness of iodine in women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) and compared to women (18-24 years) in the control group. (time frame: T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769009, which also lists 1 linked publication.
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 5 Feb 2025.