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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608138
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Center for Health Technology and Services Research
Information provided by (Responsible Party):
Universidade do Porto

Brief 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.


Condition or disease Intervention/treatment
Urinary Iodine Status in School Aged Children Other: Iodine status among portuguese school children

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.

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Study Type : Observational
Actual Enrollment : 2018 participants
Time Perspective: Cross-Sectional
Official Title: Iodine Status in Portuguese Children and the Role of Salt Fortification in School Canteens
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium
Drug Information available for: Iodine

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



Primary Outcome Measures :
  1. Urinary Iodine [ Time Frame: One time point collection ]
  2. Salt Iodine [ Time Frame: One time point collection ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
School aged children (6-12 years)
Criteria

Inclusion Criteria: School children aged 6 to 12 -

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608138


Locations
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Portugal
CINTESIS - Faculty of Medicine of the University of Porto
Porto, Portugal, 4200-450
Sponsors and Collaborators
Universidade do Porto
Center for Health Technology and Services Research
Investigators
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Principal Investigator: Conceição Calhau, PhD CINTESIS, Faculty of Medicine of the University of Porto

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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT02608138    
Other Study ID Numbers: 153NU2
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: January 2016
Keywords provided by Universidade do Porto:
iodine
urine
children
schools
cognitive performance
salt fortification
Additional relevant MeSH terms:
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Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs