NCT04524013

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
875

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

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

August 12, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

August 12, 2020

Last Update Submit

November 21, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Urinary iodine concentration

    urinary iodine concentration in spot urine samples

    Baseline

Secondary Outcomes (7)

  • Urinary creatinine concentration

    Baseline

  • Urinary sodium concentration

    Baseline

  • Urinary fluoride concentration

    Baseline

  • Thyroid stimulating hormone

    Baseline

  • T3

    Baseline

  • +2 more secondary outcomes

Other Outcomes (4)

  • Weight

    Baseline

  • Height

    Baseline

  • Omega 3 intake

    Baseline

  • +1 more other outcomes

Study Arms (2)

School aged children

Other: There is no intervention. It is an observational study.

Pregnant women

Other: There is no intervention. It is an observational study.

Interventions

There is no intervention. It is an observational study.OTHER

There is not intervention

Pregnant womenSchool aged children

Eligibility Criteria

Age6 Years - 44 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIn the group of pregnant women only pregnant women can participate. The only criteria is that the be pregnant.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • Healthy
  • for pregnant women: confirmed pregnancy
  • living in Switzerland for min 1 year

You may not qualify if:

  • no history of major medical illness
  • no iodine containing contrast agents or medication in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

  • Fischer L, Andersson M, Braegger C, Herter-Aeberli I; Swiss Iodine Study Collaborators. Iodine intake in the Swiss population 100 years after the introduction of iodised salt: a cross-sectional national study in children and pregnant women. Eur J Nutr. 2024 Mar;63(2):573-587. doi: 10.1007/s00394-023-03287-6. Epub 2023 Dec 23.

    PMID: 38141138DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

spot urine samples from women and children, dried blood spots from women.

Study Design

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

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 24, 2020

Study Start

October 1, 2020

Primary Completion

August 31, 2022

Study Completion

July 30, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)