Swiss National Iodine Survey 2015

Healthy Subjects Clinical Trial

— SIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312466
• Other study ID #: SIS 2015
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Healthy Subjects

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