- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02312466
Swiss National Iodine Survey 2015 (SIS)
September 15, 2020 updated by: Isabelle Herter-Aeberli
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
1430
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8092
- Human Nutrition Laboratory, ETH Zurich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 44 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
school aged children, 6-12 years pregnant women, 18-44 years women of reproductive age, 18-44 years
Description
Inclusion Criteria:
- Healthy
- Living in Switzerland for at least 1 year
- For pregnant women: singleton pregnancy
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Pregnant women
|
School aged children
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Women of reproductive age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age
Time Frame: Baseline
|
analysis of urine samples
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Population mean thyroglobulin
Time Frame: Baseline
|
Analysis of venous blood samples.
Assessed only in women
|
Baseline
|
Population mean thyroid stimulating hormone
Time Frame: Baseline
|
Analysis of venous blood samples.
Assessed only in women
|
Baseline
|
Population mean thyroxine
Time Frame: Baseline
|
Analysis of venous blood samples.
Assessed only in women
|
Baseline
|
Median urinary sodium concentration
Time Frame: Baseline
|
Baseline
|
|
Median urinary creatinin concentration
Time Frame: Baseline
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean height of school aged children and women of reproductive age
Time Frame: Baseline
|
Baseline
|
|
Mean weight of school aged children and women of reproductive age
Time Frame: Baseline
|
Baseline
|
|
Median urinary fluoride
Time Frame: Baseline
|
Analyzed in urine samples from school aged children only.
|
Baseline
|
Population mean folate status
Time Frame: Baseline
|
Analysis of red blood cell folate and plasma folate in venous blood samples.
|
Baseline
|
Populations mean iron status
Time Frame: Baseline
|
Serum analysis: ferritin, transferrin receptor; in women of reproductive age and pregnant women.
|
Baseline
|
Individual inflammatory state
Time Frame: Baseline
|
Serum analysis of CRP and AGP, analyzed only in women
|
Baseline
|
Intake of iodine in micro grams per day
Time Frame: Baseline
|
iodine intake assessed by food frequency questionnaire, only in women
|
Baseline
|
% of households with adequate iodine coverage
Time Frame: Baseline
|
Salt samples only collected from children (subgroup)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
December 3, 2014
First Submitted That Met QC Criteria
December 5, 2014
First Posted (Estimate)
December 9, 2014
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 15, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- SIS 2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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