Iodine Status in Portuguese Children and the Role of Salt Fortification in School Canteens (IoGeneration)

October 24, 2016 updated by: Universidade do Porto

It is well known that insufficient iodine intakes impairs the production of thyroid hormones, essential for cognitive development and healthy growth.

Although the World Health Organization (WHO) promotes public health measures for an adequate iodine consumption, it is estimated that one in three school age children remain iodine deficient worldwide. Whereas there is no mandatory iodisation programs in Portugal, young infants are among the most vulnerable to iodine deficiency due to their special requirements.

Therefore, the present study aims to evaluate iodine status in school age Portuguese children (6-12y), compare iodine status in children, cognitive outcomes and thyroid health and monitor the use of iodised salt in school canteens exploring potential implications in children's iodine status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Iodine is essential for the synthesis of thyroid hormones. Thyroid hormones, especially during periods of increased susceptibility, are crucial for neurodevelopment. Inadequate levels of iodine in the diet may lead to a strong and decisive cognitive impairment which poses a major public health challenge. The World Health Organization prioritized the intake of iodine and recommends the universal enrichment of salt with iodine, so it may reach the general population. In 2013 the Portuguese Department of Education (DGE) issued, as a result of the collaboration with the Portuguese Department of Health (DGS) under the National Program to Promote Healthy Eating a directive introducing the use of iodized salt in school canteens. To ensure the effectiveness and the impact of these policies in Portugal, this project aims to (1) evaluate urinary iodine status in school children (6-12 y), (2) monitor the use of iodized salt in schools, (3) explore potential associations between these parameters. The results of this project will be used to educate food service professionals regarding the use of iodized salt and inform the community about the impact of iodine in health, based on the Norwegian model.

In this study a total of 4800 school aged children will be recruited from approximately 160 schools in the north of Portugal. Parents will be asked to complete the CBCL 6-18, Child Behaviour Checklist and a comprehensive questionnaire which will collect data regarding the child lifestyle and diet. A urine sample will be collected from each participant in school and the Raven's Colored Progressive Matrices will be applied to evaluate children cognitive performance. Anthropometry measurements will be also collected.

Study Type

Observational

Enrollment (Actual)

2018

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

  • Portugal
      • Porto, Portugal, 4200-450
        • CINTESIS - Faculty of Medicine of the University of Porto

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 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

School aged children (6-12 years)

Description

Inclusion Criteria: School children aged 6 to 12 -

Exclusion Criteria:

-

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

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Urinary iodine will be measured at one point in time in school children aged 6-12. A sample of salt used at home and schools will be collected to estimate iodine levels.
Other: Iodine status among portuguese school children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary Iodine
Time Frame: One time point collection
One time point collection
Salt Iodine
Time Frame: One time point collection
One time point collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Performance
Time Frame: One time point collection
Raven's Colored Progressive Matrices
One time point collection
Urinary Creatinine
Time Frame: One time point collection
One time point collection
Height
Time Frame: One time point collection
One time point collection
Weight
Time Frame: One time point collection
One time point collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Center for Health Technology and Services Research

Investigators

  • Principal Investigator: Conceição Calhau, PhD, CINTESIS, Faculty of Medicine of the University of Porto

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

April 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 153NU2

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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