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Iodine-129 Tracer Method for Investigating Human Iodine Metabolism

NCT02955745 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2017-06-12

No results posted yet for this study

Summary

Current iodine requirements defined for pregnancy and lactation are rough factorial estimates extrapolated from older studies in adults that used radioactive iodine tracers. To ensure optimal thyroid function in these vulnerable groups, a tracer method that could be safely used to accurately define iodine requirements would be valuable. Iodine-129 (129I), a long-lived semi-stable isotope with no health risks, could be used as a tracer, but the analytic challenges are formidable. However, we have developed an ICP-MS method to measure pp-billion (10-9) to pp-trillion (10-12) quantities of 129I in biological samples. In this project we will perform a study in which iodine-replete adult subjects will consume an oral dose of 129I. We will quantify 129I kinetic patterns in plasma, urine and stools after the oral dose, and use these data to derive tracer absorption, retention and excretion rates. This trial will allow us to define optimized procedures for the routine application of this method to assess iodine metabolism in humans. The use of 129I may prove to be a breakthrough technique to safely assess iodine metabolism and requirements in pregnant/lactating women in order to ensure healthy thyroid function in these age groups.

Conditions

  • Healthy Volunteers

Interventions

OTHER

Iodine-129

The present study is an observational study and does not therefore include an investigational product in the proper sense because the used tracer (semi-stable iodine isotope) has no physiological effect on the participants. 129I will be used as tracer to measure appearance in plasma, urine and stools after the oral administered of the 129I-tracer.

Sponsors & Collaborators

  • Swiss Federal Food Safety and Veterinary Office

    collaborator UNKNOWN

  • University Hospital, Zürich

    collaborator OTHER

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Michael B Zimmermann, MD · ETH Zurich

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-01-17
Completion
2017-01-17

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955745 on ClinicalTrials.gov