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

Urinary Iodine Status in School Aged Children Clinical Trial

— IoGeneration  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608138
• Other study ID #: 153NU2
• Status: Completed
• Phase: N/A
• First received: November 16, 2015
• Last updated: October 24, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2018
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria: School children aged 6 to 12 -

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Urinary Iodine Status in School Aged Children

Intervention

Other:
• Iodine status among portuguese school children

Locations

Country	Name	City	State
Portugal	CINTESIS - Faculty of Medicine of the University of Porto	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Center for Health Technology and Services Research

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Iodine		One time point collection	Yes
Primary	Salt Iodine		One time point collection	Yes
Secondary	Cognitive Performance	Raven's Colored Progressive Matrices	One time point collection	Yes
Secondary	Urinary Creatinine		One time point collection	Yes
Secondary	Height		One time point collection	Yes
Secondary	Weight		One time point collection	Yes