Comparison of I-FFQ and Two Reference Methods | NCT05934006

Studies
Comparison of I-FFQ and Two Reference Methods

NCT05934006

Sponsor

University of Bergen

Status

Completed

Last Update Posted

Jul 6, 2023Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Iodine Deficiency

Interventions

spot urine samples

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2021Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jun 15, 2022Actual

First Submitted Date

Mar 6, 2023

First Submission Date that Met QC Criteria

Jul 3, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2023

Last Update Posted Date

Jul 6, 2023Actual

Name	Class
National Dairy Council	OTHER
Institute of Marine Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spot urine samples	Biological	No intervention, but measurement of urinary iodine concentration by 6 repeated spot urine samples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

healthy women aged 18-40 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hanne Rosendahl-Riise, PhD	University of Bergen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Bergen		Bergen		5021	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided