Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability in Iodine Nutrition Studies

NCT ID: NCT03731312

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-05-04

Brief Summary

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Iodine status in populations is assessed using urinary iodine concentration (UIC) measured in spot urine samples. The iodine intake is classified as deficient, sufficient, or excessive iodine based on the median UIC (mUIC). However, this approach has limitations, as it does not quantify the prevalence of individuals with habitually deficient or excess iodine intakes. The EAR cut-point method has the potential to quantify prevalence of iodine deficiency and excess. However, little is known about the effects of the inter- and intra-individual variance of UIC.

The aim of the study is to quantify the intra-individual variability in dietary iodine intake. The overall goal is to estimate the prevalence of iodine deficiency and excess in the study population and propose sample size recommendations for future iodine nutrition population studies. The results will provide evidence guiding international recommendations for iodine nutrition studies.

Detailed Description

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Conditions

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Iodine Deficiency

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study group

We will collect two repeated spot urine samples, a DBS sample and obtain weight in all 600 study participants. In a randomly selected subsample (n=200) a third repeat spot urine sample and one 24 h urine will additionally be collected.

No intervention

Intervention Type OTHER

This is an observational study and no interventions will be administered.

Interventions

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No intervention

This is an observational study and no interventions will be administered.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Non-pregnant
* Non-lactating
* Non-smoking
* Residence in Switzerland ≥12 months
* Generally healthy
* No family history of goiter
* No exposure to iodine containing contrast agents during the last 12 months - Informed consent given

Exclusion Criteria

* Participant is not able to understand the study information or procedure, e.g. due to linguistic barriers
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Rigutto-Farebrother, PhD

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich

Locations

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ETH Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Arns-Glaser L, Zihlmann R, Gessler S, Verkaik-Kloosterman J, Zandberg L, Assey VD, Rigutto-Farebrother J, Braegger CP, Zimmermann MB, Andersson M. Estimating habitual iodine intake and prevalence of inadequacy from spot urine in cross-sectional studies: a modeling analysis to determine the required sample size. Am J Clin Nutr. 2023 Jun;117(6):1270-1277. doi: 10.1016/j.ajcnut.2023.03.012. Epub 2023 May 4.

Reference Type DERIVED
PMID: 37270291 (View on PubMed)

Other Identifiers

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VIOLET

Identifier Type: -

Identifier Source: org_study_id

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