- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04524013
Swiss National Iodine Survey 2020
November 21, 2023 updated by: Isabelle Herter-Aeberli
This study will assess iodine status in school aged children and pregnant women is Switzerland.
In addition, thyroid status and omega-3 index will be assessed in pregnant women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
875
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
Sampling Method
Probability Sample
Study Population
Both groups: nationally representative sample selected through schools (children) and gynecologists (women).
School aged children: aged between 6 and 12 years Pregnant women: aged between 18 and 44 years, pregnant
Description
Inclusion Criteria:
- Healthy
- for pregnant women: confirmed pregnancy
- living in Switzerland for min 1 year
Exclusion Criteria:
- no history of major medical illness
- no iodine containing contrast agents or medication in the past 6 months
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pregnant women
|
There is not intervention
|
|
School aged children
|
There is not intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary iodine concentration
Time Frame: Baseline
|
urinary iodine concentration in spot urine samples
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary creatinine concentration
Time Frame: Baseline
|
Urinary creatinine concentration in spot urine samples
|
Baseline
|
|
Urinary sodium concentration
Time Frame: Baseline
|
Urinary sodium concentration in spot urine samples
|
Baseline
|
|
Urinary fluoride concentration
Time Frame: Baseline
|
Urinary fluoride concentration in spot urine samples
|
Baseline
|
|
Thyroid stimulating hormone
Time Frame: Baseline
|
TSH from dried blood spots
|
Baseline
|
|
T3
Time Frame: Baseline
|
T3 from dried blood spots
|
Baseline
|
|
T4
Time Frame: Baseline
|
T4 from dried blood spots
|
Baseline
|
|
Omega 3 index
Time Frame: Baseline
|
Omega 3 index from dried blood spots
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: Baseline
|
Baseline
|
|
|
Weight
Time Frame: Baseline
|
Baseline
|
|
|
Omega 3 intake
Time Frame: Baseline
|
Assessment of omega 3 intake using a food frequency questionnaire
|
Baseline
|
|
Depressive symptoms
Time Frame: Baseline
|
Assessment of depressive symptoms using the Edinburgh Postnatal Depression Scale (EPDS).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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 (Actual)
October 1, 2020
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
August 12, 2020
First Submitted That Met QC Criteria
August 19, 2020
First Posted (Actual)
August 24, 2020
Study Record Updates
Last Update Posted (Actual)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2020-00192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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