Caribbean Island Urinary Iodine Survey 2018

NCT ID: NCT04388540

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3080 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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

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Iodine Deficiency

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Jamaica

School aged children 6 - 12 years living in Jamaica

No interventions assigned to this group

Trinidad and Tobago

School aged children 6 - 12 years living in Trinidad and Tobago

No interventions assigned to this group

Belize

School aged children 6 - 12 years living in Belize

No interventions assigned to this group

Barbados

School aged children 6 - 12 years living in Barbados

No interventions assigned to this group

St. Lucia

School aged children 6 - 12 years living in St. Lucia

No interventions assigned to this group

Grenada

School aged children 6 - 12 years living in Grenada

No interventions assigned to this group

St. Vincent & the Grenadines

School aged children 6 - 12 years living in St. Vincent \& the Grenadines

No interventions assigned to this group

Antigua

School aged children 6 - 12 years living in Antigua

No interventions assigned to this group

Dominica

School aged children 6 - 12 years living in Dominica

No interventions assigned to this group

St. Kitts and Nevis

School aged children 6 - 12 years living in St. Kitts and Nevis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pan American Health Organization

OTHER

Sponsor Role collaborator

UNICEF

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Zimmermann, Dr. Prof.

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich, Iodine Global Network

Locations

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Pan American Health Organization

St John's, , Antigua and Barbuda

Site Status

Pan American Health Organization

Bridgetown, , Barbados

Site Status

Ministry of Health

Belize City, , Belize

Site Status

Pan American Health Organization

Roseau, , Dominica

Site Status

Pan American Helath Organization

The Lime, , Grenada

Site Status

The University of the West Indies

Mona, Kingston, Jamaica

Site Status

Ministry of Health

Basseterre, , Saint Kitts and Nevis

Site Status

Ministry of Health and Wellness

Castries, , Saint Lucia

Site Status

Pan American Health Organization

Kingstown, , Saint Vincent and the Grenadines

Site Status

University of the West Indies

Port of Spain, , Trinidad and Tobago

Site Status

Countries

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Antigua and Barbuda Barbados Belize Dominica Grenada Jamaica Saint Kitts and Nevis Saint Lucia Saint Vincent and the Grenadines Trinidad and Tobago

Other Identifiers

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CRUISE

Identifier Type: -

Identifier Source: org_study_id

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