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Completed

NCT Number: NCT04388540

Caribbean Island Urinary Iodine Survey 2018

Many of the Caribbean island nations have no data on iodine status in their populations.

Iodine deficiency in children can reduce IQ but can be easily corrected through a program of salt iodization.

The study will be located at 11 islands of the Caribbean region. At each of the 11 study sites, we will measure the iodine status in school-age children by collecting morning spot urine samples for measurement of urinary iodine concentration (UIC). We will also measure height and weight in all children. We will collect a repeat, next-day spot urine sample in 1/3rd of children to adjust for intra-individual variation in spot UIC and calculate the distribution of population intake.

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Key information

Conditions

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pan American Health Organization, St John's, Antigua and Barbuda

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About this study

In well-controlled randomized trials in Europe and New Zealand, even mild-to-moderate iodine deficiency in school-age children reduces IQ (1); thus, its critical to avoid iodine deficiency in this age group. In countries effected by iodine deficiency, its sustainable elimination through iodized salt can contribute to socioeconomic development. The goal to eliminate iodine deficiency was first adopted globally at the World Summit for Children in 1990, and in 1994, WHO and UNICEF concluded that salt iodization is a safe, cost-effective and sustainable strategy to control iodine deficiency (2). In 2005, the World Health Assembly called on national governments to report on their iodine nutrition every three years. However, before the present survey, the ten countries included in this project had no data on iodine status in their populations, and household access to adequately iodized salt was also unknown. Thus, the study objectives were:

  • Assess the distribution of iodine intake of school-age children and their iodine status by measuring urinary iodine concentrations;
  • Assess the iodine content of household salt and of seasoning powders;
  • Based on the above, provide the preliminary evidence base on which to make initial recommendations for iodine strategy/programs in the region.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age at study enrolment 6 to 12 years
  • healthy; no known history of major medical illnesses and taking no chronic medications;
  • residence at the respective study site for 12 months or longer;
  • no use of iodine containing dietary supplements during the last 6 months;
  • no use of X-ray / CT contrast agent or iodine containing medication within the last year.

Treatment and study plan

Primary outcomes

  1. Iodine status (UIC in spot urine samples)

    Time frame: March 2018 to May 2019

    Assessment of iodine status based on median urinary iodine concentration in spot urine samples

Secondary outcomes

  1. Iodine content in salt

    Time frame: January 2019 to May 2019

    Measurement of iodine concentration in salt samples brought in by participants

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Pan American Health Organization
  • UNICEF

Registry information

Acronym: CRUISE

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 14, 2020
Registry last updated
Jan 25, 2021

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.

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