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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05934006
Other study ID # 2021/232247
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 10, 2021
Est. completion date June 15, 2022

Study information

Verified date July 2023
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 15, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
spot urine samples
No intervention, but measurement of urinary iodine concentration by 6 repeated spot urine samples

Locations

Country Name City State
Norway University of Bergen Bergen

Sponsors (3)

Lead Sponsor Collaborator
University of Bergen Institute of Marine Research, National Dairy Council

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 One week
Primary Comparison of FFQ with urinary iodine concentration Comparison of estimated iodine intake from food-frequency questionnaire (FFQ) with urinary iodine concentration (UIC) One week
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