Caribbean Island Urinary Iodine Survey 2018

Iodine Deficiency Clinical Trial

— CRUISE  

Official title:

Caribbean Island Urinary Iodine Survey 2018

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388540
• Other study ID #: CRUISE
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2021
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3080
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Iodine Deficiency

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Pan American Health Organization, UNICEF

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Iodine content in salt	Measurement of iodine concentration in salt samples brought in by participants	January 2019 to May 2019