Dietary Iron Requirements

NCT07139821 | Recruiting

• 1 other identifier: 2025-036-PBRC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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

Keywords

Iron absorption; Iron losses; Iron requirements; Iron deficiency; Iron deficiency anemia; Iron isotopes

Outcome Measures

Primary Outcomes (1)

• Iron isotope composition in blood

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

  12 weeks

Study Arms (1)

US males and premenopausal females

EXPERIMENTAL

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

Other: Stable iron isotope

Interventions

Stable iron isotope OTHER

Stable iron isotopes will be used to determine iron requirements.

US males and premenopausal females

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Cornell University: collaborator

Study Sites (2)

LSU Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Cornell University

Ithaca, New York, 14853, United States

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Stephen Hennigar, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 24, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)