- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05934006
Comparison of I-FFQ and Two Reference Methods
July 3, 2023 updated by: University of Bergen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bergen, Norway, 5021
- University of Bergen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
healthy women aged 18-40 years
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- being pregnant, lactating, or having known thyroid disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
One week
|
|
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)
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hanne Rosendahl-Riise, PhD, University of Bergen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021/232247
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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