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CompletedNCT04388540CRUISEUpdated Jan 25, 2021

Caribbean Island Urinary Iodine Survey 2018

An observational study in Iodine Deficiency, sponsored by Swiss Federal Institute of Technology. Completed at 10 sites in 10 countries. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-25.

Sponsored by Swiss Federal Institute of Technology · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
3,080
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Iodine Deficiency
03

In context

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children of school age

Eligibility criteria

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.
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
3,080 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Iodine status (UIC in spot urine samples)

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

    Time frame: March 2018 to May 2019

Secondary outcomes

  1. Iodine content in salt

    Measurement of iodine concentration in salt samples brought in by participants

    Time frame: January 2019 to May 2019

07

Study locations

10 sites
  • Pan American Health Organization
    St. Johns, Antigua and Barbuda
  • Pan American Health Organization
    Bridgetown, BB11000, Barbados
  • Ministry of Health
    Belize City, Belize
  • Pan American Health Organization
    Roseau, Dominica
  • Pan American Helath Organization
    The Lime, Grenada
  • The University of the West Indies
    Mona, Kingston, Jamaica
  • Ministry of Health
    Basseterre, Saint Kitts and Nevis
  • Ministry of Health and Wellness
    Castries, Saint Lucia
  • Pan American Health Organization
    Kingstown, Saint Vincent and the Grenadines
  • University of the West Indies
    Port Of Spain, Trinidad and Tobago
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in May 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2020
First posted
May 14, 2020
StartActual
Jan 1, 2018
Primary completionActual
May 31, 2018
CompletionActual
Jun 30, 2019
Last update
Jan 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04388540
Collaborators
Pan American Health Organization, UNICEF
Responsible party
Sponsor
First posted
May 14, 2020
Start date
Jan 1, 2018
Primary completion
May 31, 2018
Completion
Jun 30, 2019
Last update
Jan 25, 2021

Study contacts

Michael B Zimmermann, Dr. Prof.
principal investigator · ETH Zurich, Iodine Global Network

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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