Iodine DeficiencyCRUISENCT04388540
Caribbean Island Urinary Iodine Survey 2018
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 10 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- How many people
- 3,080 participants
- Where
- 10 sitesin 10 countries
- Study dates
- 1 Jan 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children of school age
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
Antigua and Barbuda1 site
Pan American Health Organization
St John's
Barbados1 site
Pan American Health Organization
Bridgetown, BB11000
Belize1 site
Ministry of Health
Belize City
Dominica1 site
Pan American Health Organization
Roseau
Grenada1 site
Pan American Helath Organization
The Lime
Saint Kitts and Nevis1 site
Ministry of Health
Basseterre
Saint Lucia1 site
Ministry of Health and Wellness
Castries
Saint Vincent and the Grenadines1 site
Pan American Health Organization
Kingstown
Trinidad and Tobago1 site
University of the West Indies
Port of Spain
About this study
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.
- Conditions
- Iodine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Iodine status (UIC in spot urine samples)
Assessment of iodine status based on median urinary iodine concentration in spot urine samples
Measured: March 2018 to May 2019
Secondary outcomes (1)
Iodine content in salt
Measurement of iodine concentration in salt samples brought in by participants
Measured: January 2019 to May 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Jan 2018
- Primary completion31 May 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Pan American Health Organization, UNICEF
- Responsible party
- Sponsor
- Investigators
- Michael B Zimmermann, Dr. Prof., Principal investigator, ETH Zurich, Iodine Global Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388540
- Sponsor's protocol ID
- CRUISE
- Acronym
- CRUISE
- Status last verified
- Jan 2021
- First submitted
- 11 May 2020
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caribbean Island Urinary Iodine Survey 2018
- ClinicalTrials.gov ID
- NCT04388540
- Acronym / sponsor ID
- CRUISE / CRUISE
- Conditions
- Iodine Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,080 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Pan American Health Organization, UNICEF
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children of school age
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Iodine content in salt
Time frame: January 2019 to May 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Zimmermann, Dr. Prof. principal investigator
ETH Zurich, Iodine Global Network
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 10 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Antigua and Barbuda, Barbados, Belize, Dominica, Grenada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iodine status (UIC in spot urine samples) (time frame: March 2018 to May 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.