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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03731312
Acronym
VIOLET
Enrollment
206
Registered
2018-11-06
Start date
2018-10-01
Completion date
2021-05-04
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iodine Deficiency

Keywords

Iodine, Urinary iodine concentration

Brief summary

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.

Interventions

OTHERNo intervention

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

Sponsors

Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Estimated daily urinary iodine excretion7 daysEstimated urinary iodine excretion (µg/day) will be obtained from urinary iodine concentration (UIC) and urinary creatinine concentration (UCC) measured in two repeat spot urine samples collected within 7 days

Secondary

MeasureTime frameDescription
Thyroid function test Tg1 dayTg concentration (µg/L) measured in dried blood spots
Measured daily iodine excretion1 dayMeasured daily iodine excretion (µg/day) will be obtained from urinary iodine concentration (UIC) and urine volume in a 24 h urine collection
Thyroid function test TSH1 dayTSH concentration (mU/L) measured in dried blood spots
Thyroid function test total T41 dayTotal T4 concentration (nmol/L) measured in dried blood spots

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026