HealthyNCT04524013
Swiss National Iodine Survey 2020
An observational study of Healthy, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
Trial summary
This study will assess iodine status in school aged children and pregnant women is Switzerland. In addition, thyroid status and omega-3 index will be assessed in pregnant women. Read more about this study
- Who is it for?
- Ages 6 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 875 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2020to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 44 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Both groups: nationally representative sample selected through schools (children) and gynecologists (women). School aged children: aged between 6 and 12 years Pregnant women: aged between 18 and 44 years, pregnant
Who may be able to join
- Healthy
- for pregnant women: confirmed pregnancy
- living in Switzerland for min 1 year
Who cannot join
- no history of major medical illness
- no iodine containing contrast agents or medication in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess iodine status in school aged children and pregnant women is Switzerland. In addition, thyroid status and omega-3 index will be assessed in pregnant women.
- Conditions
- Healthy
- Being tested
- There is no intervention. It is an observational study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention. It is an observational study.Other
There is not intervention
| Study group | Role | What they receive |
|---|---|---|
| School aged children | Not described Receives: Other: There is no intervention. It is an observational study. | |
| Pregnant women | Not described Receives: Other: There is no intervention. It is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration
urinary iodine concentration in spot urine samples
Measured: Baseline
Secondary outcomes (7)
Urinary creatinine concentration
Urinary creatinine concentration in spot urine samples
Measured: Baseline
Urinary sodium concentration
Urinary sodium concentration in spot urine samples
Measured: Baseline
Urinary fluoride concentration
Urinary fluoride concentration in spot urine samples
Measured: Baseline
Thyroid stimulating hormone
TSH from dried blood spots
Measured: Baseline
T3
T3 from dried blood spots
Measured: Baseline
T4
T4 from dried blood spots
Measured: Baseline
Omega 3 index
Omega 3 index from dried blood spots
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Oct 2020
- Primary completion31 Aug 2022
- Study completion30 Jul 2023
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 HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 875 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Epidemiology and Health Services, Unisanté, Lausanne, University Children's Hospital, Zurich
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524013
- Sponsor's protocol ID
- 2020-00192
- Status last verified
- Nov 2023
- First submitted
- 12 Aug 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fischer L, Andersson M, Braegger C, Herter-Aeberli I; Swiss Iodine Study Collaborators. Iodine intake in the Swiss population 100 years after the introduction of iodised salt: a cross-sectional national study in children and pregnant women. Eur J Nutr. 2024 Mar;63(2):573-587. doi: 10.1007/s00394-023-03287-6. Epub 2023 Dec 23.
PubMed 38141138
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss National Iodine Survey 2020
- ClinicalTrials.gov ID
- NCT04524013
- Acronym / sponsor ID
- 2020-00192
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 875 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Department of Epidemiology and Health Services, Unisanté, Lausanne, University Children's Hospital, Zurich
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 24 Aug 2020 (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.
This study will assess iodine status in school aged children and pregnant women is Switzerland. In addition, thyroid status and omega-3 index will be assessed in pregnant women.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School aged children | – | Other: There is no intervention. It is an observational study. |
| Pregnant women | – | Other: There is no intervention. It is an observational study. |
Who may qualify
- Ages
- 6 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Both groups: nationally representative sample selected through schools (children) and gynecologists (women). School aged children: aged between 6 and 12 years Pregnant women: aged between 18 and 44 years, pregnant
Key inclusion criteria (3 listed)
- Healthy
- for pregnant women: confirmed pregnancy
- living in Switzerland for min 1 year
Key exclusion criteria (2 listed)
- no history of major medical illness
- no iodine containing contrast agents or medication in the past 6 months
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 |
|---|---|---|
| There is no intervention. It is an observational study.There is not intervention | Other | Pregnant women, School aged children |
Primary outcome
Urinary iodine concentration
Time frame: Baseline
urinary iodine concentration in spot urine samples
7 secondary outcomes
Urinary creatinine concentration
Time frame: Baseline
Urinary sodium concentration
Time frame: Baseline
Urinary fluoride concentration
Time frame: Baseline
Thyroid stimulating hormone
Time frame: Baseline
T3
Time frame: Baseline
T4
Time frame: Baseline
Omega 3 index
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 38141138Fischer L, Andersson M, Braegger C, Herter-Aeberli I; Swiss Iodine Study Collaborators. Iodine intake in the Swiss population 100 years after the introduction of iodised salt: a cross-sectional national study in children and pregnant women. Eur J Nutr. 2024 Mar;63(2):573-587. doi: 10.1007/s00394-023-03287-6. Epub 2023 Dec 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary iodine concentration (time frame: Baseline). 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 NCT04524013, 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 22 Nov 2023.