NCT05934006

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

March 6, 2023

Last Update Submit

July 3, 2023

Conditions

Iodine Deficiency

Keywords

validationfood frequency questionnaire

Outcome Measures

Primary Outcomes (2)

  • 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

  • Comparison of FFQ with urinary iodine concentration

    Comparison of estimated iodine intake from food-frequency questionnaire (FFQ) with urinary iodine concentration (UIC)

    One week

Interventions

spot urine samplesBIOLOGICAL

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy women aged 18-40 years

You may qualify if:

  • 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

You may not qualify if:

  • being pregnant, lactating, or having known thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, 5021, Norway

Location

Study Officials

  • Hanne Rosendahl-Riise, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

July 6, 2023

Study Start

August 10, 2021

Primary Completion

January 1, 2022

Study Completion

June 15, 2022

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)