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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02312466
Other study ID # SIS 2015
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2015
Est. completion date December 2016

Study information

Verified date September 2020
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1430
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Human Nutrition Laboratory, ETH Zurich Zurich

Sponsors (2)

Lead Sponsor Collaborator
Isabelle Herter-Aeberli Federal Food Safety and Veterinary Office (Switzerland)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Mean height of school aged children and women of reproductive age Baseline
Other Mean weight of school aged children and women of reproductive age Baseline
Other Median urinary fluoride Analyzed in urine samples from school aged children only. Baseline
Other Population mean folate status Analysis of red blood cell folate and plasma folate in venous blood samples. Baseline
Other Populations mean iron status Serum analysis: ferritin, transferrin receptor; in women of reproductive age and pregnant women. Baseline
Other Individual inflammatory state Serum analysis of CRP and AGP, analyzed only in women Baseline
Other Intake of iodine in micro grams per day iodine intake assessed by food frequency questionnaire, only in women Baseline
Other % of households with adequate iodine coverage Salt samples only collected from children (subgroup) Baseline
Primary Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age analysis of urine samples Baseline
Secondary Population mean thyroglobulin Analysis of venous blood samples. Assessed only in women Baseline
Secondary Population mean thyroid stimulating hormone Analysis of venous blood samples. Assessed only in women Baseline
Secondary Population mean thyroxine Analysis of venous blood samples. Assessed only in women Baseline
Secondary Median urinary sodium concentration Baseline
Secondary Median urinary creatinin concentration Baseline
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