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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03602404
Other study ID # ITURN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date February 21, 2020

Study information

Verified date May 2022
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1592
Est. completion date February 21, 2020
Est. primary completion date February 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 13 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Papua New Guinea University of Papua New Guinea Sia Morobe
Russian Federation Almazov Medical Research Center Saint Petersburg

Sponsors (3)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology Almazov National Medical Research Centre, University of Papua New Guinea

Countries where clinical trial is conducted

Papua New Guinea,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Urinary iodine concentration Measured in spot urine samples and 24 h urine collections 17 months
Secondary Urinary creatinine concentration Measured in spot urine samples and 24 h urine collections 17 months
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