NCT02312466

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

December 3, 2014

Last Update Submit

September 15, 2020

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

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

    analysis of urine samples

    Baseline

Secondary Outcomes (5)

  • Population mean thyroglobulin

    Baseline

  • Population mean thyroid stimulating hormone

    Baseline

  • Population mean thyroxine

    Baseline

  • Median urinary sodium concentration

    Baseline

  • Median urinary creatinin concentration

    Baseline

Other Outcomes (8)

  • Mean height of school aged children and women of reproductive age

    Baseline

  • Mean weight of school aged children and women of reproductive age

    Baseline

  • Median urinary fluoride

    Baseline

  • +5 more other outcomes

Study Arms (3)

School aged children

Pregnant women

Women of reproductive age

Eligibility Criteria

Age6 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

school aged children, 6-12 years pregnant women, 18-44 years women of reproductive age, 18-44 years

You may qualify if:

  • Healthy
  • Living in Switzerland for at least 1 year
  • For pregnant women: singleton pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

  • Andersson M, Hunziker S, Fingerhut R, Zimmermann MB, Herter-Aeberli I. Effectiveness of increased salt iodine concentration on iodine status: trend analysis of cross-sectional national studies in Switzerland. Eur J Nutr. 2020 Mar;59(2):581-593. doi: 10.1007/s00394-019-01927-4. Epub 2019 Mar 1.

    PMID: 30843107DERIVED

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 9, 2014

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

CH(1)