Recruiting

Iron Needs

Sponsor:

Pennington Biomedical Research Center

Code:

NCT07139821

Conditions

Iron Absorption

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Stable iron isotope

Study Details

Brief summary:

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.

Conditions

Iron Absorption

Study ID

NCT07139821

Start date

Feb 6, 2026

Status verified date

Feb, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: US males and premenopausal females

A representative sample of adult males and premenopausal females living in the US

Interventions

Stable iron isotope

Stable iron isotopes will be used to determine iron requirements.

Primary outcome measure

  • Iron isotope composition in blood [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Stephen Hennigar, PhD

225-763-2612stephen.hennigar@pbrc.edu

Locations

LSU Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Stephen Hennigar, PhD

225-763-2612stephen.hennigar@pbrc.edu

Cornell University

Recruiting

Ithaca, New York, United States, 14853

Contacts

Kimberly O'Brien, PhD

607-255-3743koo4@cornell.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Apr 29, 2026

Last verified

Feb, 2026

Keywords

  • Iron absorption
  • Iron losses
  • Iron requirements
  • Iron deficiency
  • Iron deficiency anemia
  • Iron isotopes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-04-29.