Clinical trial NCT04388540: Caribbean Island Urinary Iodine Survey 2018
Official title: Caribbean Island Urinary Iodine Survey 2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iodine Deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Pan American Health Organization
name: UNICEF
First posted: 2020-05-14
Enrollment: 3080
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children of school age

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.

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.

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.

Primary outcomes:
measure: Iodine status (UIC in spot urine samples)
timeFrame: March 2018 to May 2019
Secondary outcomes:
measure: Iodine content in salt
timeFrame: January 2019 to May 2019
Other outcomes:
Locations:
city: St. Johns
country: Antigua and Barbuda
facility: Pan American Health Organization
city: Bridgetown
country: Barbados
facility: Pan American Health Organization
city: Belize City
country: Belize
facility: Ministry of Health
city: Roseau
country: Dominica
facility: Pan American Health Organization
city: The Lime
country: Grenada
facility: Pan American Helath Organization
city: Mona
country: Jamaica
facility: The University of the West Indies
state: Kingston
city: Basseterre
country: Saint Kitts and Nevis
facility: Ministry of Health
city: Castries
country: Saint Lucia
facility: Ministry of Health and Wellness
city: Kingstown
country: Saint Vincent and the Grenadines
facility: Pan American Health Organization
city: Port Of Spain
country: Trinidad and Tobago
facility: University of the West Indies
Study officials:
affiliation: ETH Zurich, Iodine Global Network
name: Michael B Zimmermann, Dr. Prof.
role: PRINCIPAL_INVESTIGATOR
References: