Caribbean Island Urinary Iodine Survey 2018

NCT04388540 | Completed

• 1 other identifier: CRUISE
• Study Type: observational
• Target: 3,080
• Locations: 8 countries
• Sites: 8

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.

Conditions

Iodine Deficiency

Outcome Measures

Primary Outcomes (1)

• Iodine status (UIC in spot urine samples)

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

  March 2018 to May 2019

Secondary Outcomes (1)

• Iodine content in salt

  January 2019 to May 2019

Study Arms (10)

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

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children of school age

You may qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Pan American Health Organization: collaborator
• UNICEF: collaborator

Study Sites (10)

Pan American Health Organization

St John's, Antigua and Barbuda

Location

Pan American Health Organization

Bridgetown, BB11000, Barbados

Location

Ministry of Health

Belize City, Belize

Location

Pan American Health Organization

Roseau, Dominica

Location

Pan American Helath Organization

The Lime, Grenada

Location

The University of the West Indies

Mona, Kingston, Jamaica

Location

Ministry of Health

Basseterre, Saint Kitts and Nevis

Location

Ministry of Health and Wellness

Castries, Saint Lucia

Location

Pan American Health Organization

Kingstown, Saint Vincent and the Grenadines

Location

University of the West Indies

Port of Spain, Trinidad and Tobago

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Spot Urine Samples

Study Officials

• Michael B Zimmermann, Dr. Prof.

  ETH Zurich, Iodine Global Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: January 1, 2018
• Primary Completion: May 31, 2018
• Study Completion: June 30, 2019
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

DO (1); JA (1); SA (1); GR (1); AN (1); BE (1); BA (1); TR (1)