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

      • Zurich, Switzerland, 8092
        • Human Nutrition Laboratory, ETH Zurich

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
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.

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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