Caribbean Island Urinary Iodine Survey 2018 (CRUISE)

January 21, 2021 updated by: Swiss Federal Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

3080

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • St. Johns, Antigua and Barbuda
        • Pan American Health Organization
      • Bridgetown, Barbados, BB11000
        • Pan American Health Organization
      • Belize City, Belize
        • Ministry of Health
      • Roseau, Dominica
        • Pan American Health Organization
      • The Lime, Grenada
        • Pan American Helath Organization
    • Kingston
      • Mona, Kingston, Jamaica
        • The University of the West Indies
      • Basseterre, Saint Kitts and Nevis
        • Ministry of Health
      • Castries, Saint Lucia
        • Ministry of Health and Wellness
      • Kingstown, Saint Vincent and the Grenadines
        • Pan American Health Organization
      • Port Of Spain, Trinidad and Tobago
        • University of the West Indies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children of school age

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Jamaica
School aged children 6 - 12 years living in Jamaica
Trinidad and Tobago
School aged children 6 - 12 years living in Trinidad and Tobago
Belize
School aged children 6 - 12 years living in Belize
Barbados
School aged children 6 - 12 years living in Barbados
St. Lucia
School aged children 6 - 12 years living in St. Lucia
Grenada
School aged children 6 - 12 years living in Grenada
St. Vincent & the Grenadines
School aged children 6 - 12 years living in St. Vincent & the Grenadines
Antigua
School aged children 6 - 12 years living in Antigua
Dominica
School aged children 6 - 12 years living in Dominica
St. Kitts and Nevis
School aged children 6 - 12 years living in St. Kitts and Nevis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
March 2018 to May 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iodine content in salt
Time Frame: January 2019 to May 2019
Measurement of iodine concentration in salt samples brought in by participants
January 2019 to May 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael B Zimmermann, Dr. Prof., ETH Zurich, Iodine Global Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CRUISE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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