Iodine DeficiencyITURNNCT03602404
Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- How many people
- 1,592 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2018to 21 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Apparently healthy school-age children and women of reproductive age
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Papua New Guinea1 site
University of Papua New Guinea
Sia, Morobe Province
About this study
Official 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
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.
- Conditions
- Iodine Deficiency
- Keywords
- Iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Estimated iodine intake
Estimated daily iodine intake of the study population derived from urinary iodine and creatinine concentrations measured in spot urine samples
Measured: 17 months
Secondary outcomes (2)
Urinary iodine concentration
Measured in spot urine samples and 24 h urine collections
Measured: 17 months
Urinary creatinine concentration
Measured in spot urine samples and 24 h urine collections
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Almazov National Medical Research Centre, University of Papua New Guinea
- Responsible party
- Principal investigator, Maria Andersson, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602404
- Sponsor's protocol ID
- ITURN
- Acronym
- ITURN
- Status last verified
- May 2022
- First submitted
- 18 Jul 2018
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03602404
- Acronym / sponsor ID
- ITURN / ITURN
- Conditions
- Iodine Deficiency
- Keywords
- Iodine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,592 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Almazov National Medical Research Centre, University of Papua New Guinea
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Apparently healthy school-age children and women of reproductive age
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimated iodine intake
Time frame: 17 months
Estimated daily iodine intake of the study population derived from urinary iodine and creatinine concentrations measured in spot urine samples
2 secondary outcomes
Urinary iodine concentration
Time frame: 17 months
Urinary creatinine concentration
Time frame: 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Papua New Guinea, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated iodine intake (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.