CRUISE: Caribbean Island Urinary Iodine Survey 2018

Sponsor
Swiss Federal Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT04388540
Collaborator
Pan American Health Organization (Other), UNICEF (Other)
3,080
10
17.9
308
17.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    3080 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Caribbean Island Urinary Iodine Survey 2018
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    May 31, 2018
    Actual Study Completion Date :
    Jun 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Iodine status (UIC in spot urine samples) [March 2018 to May 2019]

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

    Secondary Outcome Measures

    1. Iodine content in salt [January 2019 to May 2019]

      Measurement of iodine concentration in salt samples brought in by participants

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pan American Health Organization St. Johns Antigua and Barbuda
    2 Pan American Health Organization Bridgetown Barbados BB11000
    3 Ministry of Health Belize City Belize
    4 Pan American Health Organization Roseau Dominica
    5 Pan American Helath Organization The Lime Grenada
    6 The University of the West Indies Mona Kingston Jamaica
    7 Ministry of Health Basseterre Saint Kitts and Nevis
    8 Ministry of Health and Wellness Castries Saint Lucia
    9 Pan American Health Organization Kingstown Saint Vincent and the Grenadines
    10 University of the West Indies Port Of Spain Trinidad and Tobago

    Sponsors and Collaborators

    • Swiss Federal Institute of Technology
    • Pan American Health Organization
    • UNICEF

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Swiss Federal Institute of Technology
    ClinicalTrials.gov Identifier:
    NCT04388540
    Other Study ID Numbers:
    • CRUISE
    First Posted:
    May 14, 2020
    Last Update Posted:
    Jan 25, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 25, 2021