Iodine Deficiency Clinical Trial
— ITURNOfficial title:
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
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 |
Verified date | May 2022 |
Source | Swiss Federal Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Papua New Guinea | University of Papua New Guinea | Sia | Morobe |
Russian Federation | Almazov Medical Research Center | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology | Almazov National Medical Research Centre, University of Papua New Guinea |
Papua New Guinea, Russian Federation,
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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