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Completed

NCT Number: NCT02608138

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

School children aged 6 to 12 -

Exclusion criteria

-

Treatment and study plan

Iodine status among portuguese school children

Other

Primary outcomes

  1. Urinary Iodine

    Time frame: One time point collection

  2. Salt Iodine

    Time frame: One time point collection

Secondary outcomes

  1. Cognitive Performance

    Time frame: One time point collection

    Raven's Colored Progressive Matrices

  2. Urinary Creatinine

    Time frame: One time point collection

  3. Height

    Time frame: One time point collection

  4. Weight

    Time frame: One time point collection

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Center for Health Technology and Services Research

Registry information

Acronym: IoGeneration

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2015
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.