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OpenTrials
Completed

NCT Number: NCT03731312

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

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.

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Key information

Conditions

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

ETH Zurich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Estimated daily urinary iodine excretion

    Time frame: 7 days

    Estimated 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 outcomes

  1. Measured daily iodine excretion

    Time frame: 1 day

    Measured daily iodine excretion (µg/day) will be obtained from urinary iodine concentration (UIC) and urine volume in a 24 h urine collection

  2. Thyroid function test TSH

    Time frame: 1 day

    TSH concentration (mU/L) measured in dried blood spots

  3. Thyroid function test total T4

    Time frame: 1 day

    Total T4 concentration (nmol/L) measured in dried blood spots

  4. Thyroid function test Tg

    Time frame: 1 day

    Tg concentration (µg/L) measured in dried blood spots

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

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

Acronym: VIOLET

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2018
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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