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NCT Number: NCT02312466

Swiss National Iodine Survey 2015

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.

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Key information

Conditions

Healthy Subjects

Age range

6 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age

    Time frame: Baseline

    analysis of urine samples

Secondary outcomes

  1. Population mean thyroglobulin

    Time frame: Baseline

    Analysis of venous blood samples. Assessed only in women

  2. Population mean thyroid stimulating hormone

    Time frame: Baseline

    Analysis of venous blood samples. Assessed only in women

  3. Population mean thyroxine

    Time frame: Baseline

    Analysis of venous blood samples. Assessed only in women

  4. Median urinary sodium concentration

    Time frame: Baseline

  5. Median urinary creatinin concentration

    Time frame: Baseline

Other outcomes

  1. Mean height of school aged children and women of reproductive age

    Time frame: Baseline

  2. Mean weight of school aged children and women of reproductive age

    Time frame: Baseline

  3. Median urinary fluoride

    Time frame: Baseline

    Analyzed in urine samples from school aged children only.

  4. Population mean folate status

    Time frame: Baseline

    Analysis of red blood cell folate and plasma folate in venous blood samples.

  5. Populations mean iron status

    Time frame: Baseline

    Serum analysis: ferritin, transferrin receptor; in women of reproductive age and pregnant women.

  6. Individual inflammatory state

    Time frame: Baseline

    Serum analysis of CRP and AGP, analyzed only in women

  7. Intake of iodine in micro grams per day

    Time frame: Baseline

    iodine intake assessed by food frequency questionnaire, only in women

  8. % of households with adequate iodine coverage

    Time frame: Baseline

    Salt samples only collected from children (subgroup)

Sponsors and collaborators

Lead sponsor

Isabelle Herter-Aeberli

Other

Collaborators

  • Federal Food Safety and Veterinary Office (Switzerland)

Registry information

Official study title

Swiss National Iodine Survey 2015; A Cross-sectional Study to Assess Iodine Status in School Children, Women of Reproductive Age and Pregnant Women

Acronym: SIS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2014
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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