- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388540
Caribbean Island Urinary Iodine Survey 2018 (CRUISE)
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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St. Johns, Antigua and Barbuda
- Pan American Health Organization
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Bridgetown, Barbados, BB11000
- Pan American Health Organization
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Belize City, Belize
- Ministry of Health
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Roseau, Dominica
- Pan American Health Organization
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The Lime, Grenada
- Pan American Helath Organization
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Kingston
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Mona, Kingston, Jamaica
- The University of the West Indies
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Basseterre, Saint Kitts and Nevis
- Ministry of Health
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Castries, Saint Lucia
- Ministry of Health and Wellness
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Kingstown, Saint Vincent and the Grenadines
- Pan American Health Organization
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Port Of Spain, Trinidad and Tobago
- University of the West Indies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Jamaica
School aged children 6 - 12 years living in Jamaica
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Trinidad and Tobago
School aged children 6 - 12 years living in Trinidad and Tobago
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Belize
School aged children 6 - 12 years living in Belize
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Barbados
School aged children 6 - 12 years living in Barbados
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St. Lucia
School aged children 6 - 12 years living in St. Lucia
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Grenada
School aged children 6 - 12 years living in Grenada
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St. Vincent & the Grenadines
School aged children 6 - 12 years living in St. Vincent & the Grenadines
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Antigua
School aged children 6 - 12 years living in Antigua
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Dominica
School aged children 6 - 12 years living in Dominica
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St. Kitts and Nevis
School aged children 6 - 12 years living in St. Kitts and Nevis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Iodine status (UIC in spot urine samples)
Time Frame: March 2018 to May 2019
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Assessment of iodine status based on median urinary iodine concentration in spot urine samples
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March 2018 to May 2019
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Iodine content in salt
Time Frame: January 2019 to May 2019
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Measurement of iodine concentration in salt samples brought in by participants
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January 2019 to May 2019
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Collaborators and Investigators
Investigators
- Principal Investigator: Michael B Zimmermann, Dr. Prof., ETH Zurich, Iodine Global Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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