Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations (ITURN)

Estimating the Usual Iodine Intake From Spot Urinary Iodine Concentrations to Obtain the Prevalence of Inadequate or Excess Iodine Intake in School-aged Children and Adults

The overall objective of this study is to develop a reliable method to obtain habitual iodine intakes from spot urinary iodine concentration (UIC) and to assess the prevalence of inadequate iodine intake in school-age children and women of reproductive age. We will evaluate different methods to estimate iodine intake from UIC and estimate the prevalence of inadequate and excess iodine intake in UIC studies conducted in populations with low, adequate and high iodine intakes using the the established estimated average requirement (EAR)/Tolerable Upper Intake Level (UL) cut-point method.

Study Overview

• Status: Completed
• Conditions: Iodine Deficiency

• Study Type: Observational
• Enrollment (Actual): 1592

Contacts and Locations

Study Locations

• Papua New Guinea
  • Morobe
    • Sia, Morobe, Papua New Guinea
      • University of Papua New Guinea
• Russian Federation
  • Saint Petersburg, Russian Federation
    • Almazov Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Apparently healthy school-age children and women of reproductive age

Description

Inclusion Criteria:

• lived in study area >= 12 months
• no reported intake of Amiodarone
• no history of thyroid dysfunction / goiter (past & present)
• no exposure to iodine containing contrast agents within the last 12 months

Second arm: Women aged 18 - 49, exclusion / inclusion criteria apply, plus non-pregnant, non-lactating.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
St. Petersburg: School aged children; Generally healthy 9 to 12 years old children
St. Petersburg: Women of reproductive age; Generally healthy non-pregnant, non-lactating women between 18 and 44 years of age
Papua New Guinea: School aged children; Generally healthy 9 to 12 years old children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated iodine intake	Estimated daily iodine intake of the study population derived from urinary iodine and creatinine concentrations measured in spot urine samples	17 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary iodine concentration	Measured in spot urine samples and 24 h urine collections	17 months
Urinary creatinine concentration	Measured in spot urine samples and 24 h urine collections	17 months

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Almazov National Medical Research Centre; University of Papua New Guinea

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): February 21, 2020

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Iodine
• Other Study ID Numbers: ITURN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No