Iodine DeficiencyNCT05934006
Comparison of I-FFQ and Two Reference Methods
An observational study of Iodine Deficiency, run by University of Bergen at 1 site in Norway.
Trial summary
Mild-to-moderate iodine deficiency remains a problem in many parts of the world, including Norway. Of particular concern are fertile, pregnant, and lactating women. The Norwegian Dairy Council developed a digital iodine-specific food frequency questionnaire (I-FFQ) for the assessment of iodine intake levels, but it… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- What is being tested?
- spot urine samples
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- 10 Aug 2021to 15 Jun 2022
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy women aged 18-40 years
Who may be able to join
- healthy women aged 18-40 years
- sufficient language skills to be able to complete the questionnaires in Norwegian
- be able to meet physically at the study center in Bergen
Who cannot join
- being pregnant, lactating, or having known thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Digital Iodine-specific Food Frequency Questionnaire With 24-hour Recall and Urinary Iodine Concentration
Mild-to-moderate iodine deficiency remains a problem in many parts of the world, including Norway. Of particular concern are fertile, pregnant, and lactating women. The Norwegian Dairy Council developed a digital iodine-specific food frequency questionnaire (I-FFQ) for the assessment of iodine intake levels, but it has yet to be validated. The main objective was thus to investigate the relative validity of the I-FFQ by comparing estimates of iodine intake obtained from the I-FFQ against a single 24-hour recall (24HR) and urinary iodine concentration (UIC) in fertile women.
- Conditions
- Iodine Deficiency
- Being tested
- spot urine samples
- Keywords
- validation, food frequency questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spot urine samplesBiological
No intervention, but measurement of urinary iodine concentration by 6 repeated spot urine samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of FFQ with 24-hour recall
Comparison of estimated dietary iodine intake from food-frequency questionnaire (FFQ) with dietary iodine intake from 24-hour recall
Measured: One week
Comparison of FFQ with urinary iodine concentration
Comparison of estimated iodine intake from food-frequency questionnaire (FFQ) with urinary iodine concentration (UIC)
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start10 Aug 2021
- Primary completion1 Jan 2022
- Study completion15 Jun 2022
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council, Institute of Marine Research
- Responsible party
- Sponsor
- Investigators
- Hanne Rosendahl-Riise, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934006
- Sponsor's protocol ID
- 2021/232247
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Digital Iodine-specific Food Frequency Questionnaire With 24-hour Recall and Urinary Iodine Concentration
- ClinicalTrials.gov ID
- NCT05934006
- Acronym / sponsor ID
- 2021/232247
- Conditions
- Iodine Deficiency
- Keywords
- validation, food frequency questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- National Dairy Council, Institute of Marine Research
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 6 Jul 2023 (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.
Mild-to-moderate iodine deficiency remains a problem in many parts of the world, including Norway. Of particular concern are fertile, pregnant, and lactating women. The Norwegian Dairy Council developed a digital iodine-specific food frequency questionnaire (I-FFQ) for the assessment of iodine intake levels, but it has yet to be validated. The main objective was thus to investigate the relative validity of the I-FFQ by comparing estimates of iodine intake obtained from the I-FFQ against a single 24-hour recall (24HR) and urinary iodine concentration (UIC) in fertile women.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy women aged 18-40 years
Key inclusion criteria (3 listed)
- healthy women aged 18-40 years
- sufficient language skills to be able to complete the questionnaires in Norwegian
- be able to meet physically at the study center in Bergen
Key exclusion criteria (1 listed)
- being pregnant, lactating, or having known thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spot urine samplesNo intervention, but measurement of urinary iodine concentration by 6 repeated spot urine samples | Biological | – |
Primary outcome
Comparison of FFQ with 24-hour recall
Time frame: One week
Comparison of estimated dietary iodine intake from food-frequency questionnaire (FFQ) with dietary iodine intake from 24-hour recall
Comparison of FFQ with urinary iodine concentration
Time frame: One week
Comparison of estimated iodine intake from food-frequency questionnaire (FFQ) with urinary iodine concentration (UIC)
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 6 Jul 2023.
- 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.
Hanne Rosendahl-Riise, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency, run by University of Bergen at 1 site in Norway.
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 3 inclusion and 1 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Comparison of FFQ with 24-hour recall (time frame: One week). The study lists 2 primary outcomes in all. 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 6 Jul 2023.