NCT02608138

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,018

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

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

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

November 16, 2015

Last Update Submit

October 24, 2016

Conditions

Urinary Iodine Status in School Aged Children

Keywords

iodineurinechildrenschoolscognitive performancesalt fortification

Outcome Measures

Primary Outcomes (2)

  • Urinary Iodine

    One time point collection

  • Salt Iodine

    One time point collection

Secondary Outcomes (4)

  • Cognitive Performance

    One time point collection

  • Urinary Creatinine

    One time point collection

  • Height

    One time point collection

  • Weight

    One time point collection

Study Arms (1)

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

Interventions

Iodine status among portuguese school childrenOTHER
1

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

School aged children (6-12 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

Study Officials

  • Conceição Calhau, PhD

    CINTESIS, Faculty of Medicine of the University of Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-01

Locations

PT(1)