Dietary Iron Requirements

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPennington Biomedical Research Center

About this trial

Dietary Reference Intakes (DRIs) for iron are based on a relatively small number of studies in European populations. This research study will determine iron needs in a representative sample of adults living in the US using the iron isotope dilution technique. Following administration and equilibration of a stable iron isotope, participants will be followed for a 12 week study period. Blood will be collected every 4 weeks and the isotopic composition will be determined. Results will help update dietary iron guidelines making sure they better match the specific needs of the US population.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and premenopausal females age 18-50 y

Previously participated in an iron stable isotope study or willing to consume an oral stable iron isotope and undergo a one-year equilibration period

Willing to refrain from iron-containing supplements for the duration of the study

Willing to refrain from tobacco smoking for the duration of the study

Disqualifiers

Females: pregnant or lactating or plans to become pregnant during the study period

Inability to provide informed consent and engage in informed consent procedures

Plans to relocate outside the study area

Trial design

Design model

Single group

Treatments tested in this trial

  • Stable iron isotope

    Other intervention

    Stable iron isotopes will be used to determine iron requirements.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: US males and premenopausal femalesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Iron isotope composition in blood

Tracer-to-tracee rate in venous blood samples collected at multiple time points

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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