Healthy SubjectsSISNCT02312466
Swiss National Iodine Survey 2015
An observational study of Healthy Subjects, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
Trial summary
The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the authorities regarding iodine content in iodized salt. As a proxy for the entire population the investigators will study school aged children, pregnant women and women of reproduction age. Read more about this study
- Who is it for?
- Ages 6 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 1,430 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Dec 2016
- 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: school aged children, 6-12 years pregnant women, 18-44 years women of reproductive age, 18-44 years
Who may be able to join
- Healthy
- Living in Switzerland for at least 1 year
- For pregnant women: singleton pregnancy
Who cannot join
- Major known medical illness: thyroid dysfunction, gastrointestinal or metabolic disorders and taking chronic medications
- For women of reproductive age: pregnancy, breastfeeding
- Use of X-ray or CT contrast agent or iodine containing medication within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swiss National Iodine Survey 2015; A Cross-sectional Study to Assess Iodine Status in School Children, Women of Reproductive Age and Pregnant Women
The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the authorities regarding iodine content in iodized salt. As a proxy for the entire population the investigators will study school aged children, pregnant women and women of reproduction age.
Read the detailed description
In a national sample of school aged children (n=990), pregnant women (n=700) and women of reproductive age (n=700) urinary iodine will be determined in order to assess iodine nutrition in Switzerland. In addition, in both groups of women a blood sample will be taken for the determination of thyroid hormones, iron- and folate status. Questionnaires will be used for the determination of dietary iodine and salt intake as well as sociodemographic parameters.
- Conditions
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| School aged children | Not described | |
| Pregnant women | Not described | |
| Women of reproductive age | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age
analysis of urine samples
Measured: Baseline
Secondary outcomes (5)
Population mean thyroglobulin
Analysis of venous blood samples. Assessed only in women
Measured: Baseline
Population mean thyroid stimulating hormone
Analysis of venous blood samples. Assessed only in women
Measured: Baseline
Population mean thyroxine
Analysis of venous blood samples. Assessed only in women
Measured: Baseline
Median urinary sodium concentration
Measured: Baseline
Median urinary creatinin concentration
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionDec 2016
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 Healthy SubjectsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Food Safety and Veterinary Office (Switzerland)
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312466
- Sponsor's protocol ID
- SIS 2015
- Acronym
- SIS
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2014
- Last updated
- 16 Sep 2020
- Results posted
- No
Publications
Andersson M, Hunziker S, Fingerhut R, Zimmermann MB, Herter-Aeberli I. Effectiveness of increased salt iodine concentration on iodine status: trend analysis of cross-sectional national studies in Switzerland. Eur J Nutr. 2020 Mar;59(2):581-593. doi: 10.1007/s00394-019-01927-4. Epub 2019 Mar 1.
PubMed 30843107
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss National Iodine Survey 2015; A Cross-sectional Study to Assess Iodine Status in School Children, Women of Reproductive Age and Pregnant Women
- ClinicalTrials.gov ID
- NCT02312466
- Acronym / sponsor ID
- SIS / SIS 2015
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,430 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Federal Food Safety and Veterinary Office (Switzerland)
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Dec 2014 (estimated)
- 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.
The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the authorities regarding iodine content in iodized salt. As a proxy for the entire population the investigators will study school aged children, pregnant women and women of reproduction age.
Detailed description
In a national sample of school aged children (n=990), pregnant women (n=700) and women of reproductive age (n=700) urinary iodine will be determined in order to assess iodine nutrition in Switzerland. In addition, in both groups of women a blood sample will be taken for the determination of thyroid hormones, iron- and folate status. Questionnaires will be used for the determination of dietary iodine and salt intake as well as sociodemographic parameters.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School aged children | – | – |
| Pregnant women | – | – |
| Women of reproductive age | – | – |
Who may qualify
- Ages
- 6 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- school aged children, 6-12 years pregnant women, 18-44 years women of reproductive age, 18-44 years
Key inclusion criteria (3 listed)
- Healthy
- Living in Switzerland for at least 1 year
- For pregnant women: singleton pregnancy
Key exclusion criteria (3 listed)
- Major known medical illness: thyroid dysfunction, gastrointestinal or metabolic disorders and taking chronic medications
- For women of reproductive age: pregnancy, breastfeeding
- Use of X-ray or CT contrast agent or iodine containing medication within the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age
Time frame: Baseline
analysis of urine samples
5 secondary outcomes
Population mean thyroglobulin
Time frame: Baseline
Population mean thyroid stimulating hormone
Time frame: Baseline
Population mean thyroxine
Time frame: Baseline
Median urinary sodium concentration
Time frame: Baseline
Median urinary creatinin concentration
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 16 Sep 2020.
- Derived from this study: PubMed 30843107Andersson M, Hunziker S, Fingerhut R, Zimmermann MB, Herter-Aeberli I. Effectiveness of increased salt iodine concentration on iodine status: trend analysis of cross-sectional national studies in Switzerland. Eur J Nutr. 2020 Mar;59(2):581-593. doi: 10.1007/s00394-019-01927-4. Epub 2019 Mar 1.
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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 Subjects, 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 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: finished, as of the sponsor's last update on 16 Sep 2020. 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?
Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age (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 NCT02312466, 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 16 Sep 2020.