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NCT Number: NCT07139821

Dietary Iron Requirements

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.

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Key information

Conditions

Iron Absorption Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LSU Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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
  • Have not donated blood 3 months prior to the start of the study and willing to refrain from donating blood for the duration of the study
  • Willing to have blood stored for future use
  • Able and willing to comply with study requirements and consent to participate

Exclusion criteria

  • 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

Treatment and study plan

Stable iron isotope

Other

Stable iron isotopes will be used to determine iron requirements.

Primary outcomes

  1. Iron isotope composition in blood

    Time frame: 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Hennigar, PhD

CONTACT

[email protected]

225-763-2612

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Cornell University

Registry information

Official study title

Dietary Iron Requirements in US Adults

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 24, 2025
Registry last updated
Apr 29, 2026

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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