NCT07517562

Brief Summary

Military personnel frequently experience declines in iron status during training and when in the field, which may compromise performance. The overall purpose of this study is to determine why the decline in iron status occurs and potential countermeasures. Participants will be given an acute dose of erythropoietin (EPO) or placebo and will complete a 90-minute load carriage exercise test. Prior to the main trial, this pilot study will determine the optimal approach to assess iron absorption following exercise (red blood cell incorporation or plasma isotope appearance), the percentage of iron incorporated into red blood cells with EPO compared to placebo, and the timing of the intervention.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 8, 2026

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

December 4, 2025

Last Update Submit

April 1, 2026

Conditions

Keywords

IronIron statusIron deficiencyIron deficiency anemiaMilitaryExercise

Outcome Measures

Primary Outcomes (4)

  • Fractional iron absorption

    Iron absorption as measured by iron incorporation into red blood cells

    14 days post-exercise

  • Plasma isotope appearance

    Plasma iron isotope appearance

    0, 30, 60, 90, 120, 180, and 360 minutes post-exercise

  • Red blood cell iron incorporation

    The calculation to determine dietary iron absorption accounts for the fact that not all absorbed iron is incorporated into red blood cells. This can either be an assumed constant of 80% or experimentally determined by administering a second isotope intravenously. Pilot testing will be used to assess whether the investigators can use 80% or whether iron uptake by red blood cells is greater after EPO compared to placebo.

    50 minutes infusion of a stable iron isotope following exercise

  • Timing of intervention

    Blood will be collected over time to ensure blood biomarkers return to baseline following EPO.

    1, 2, 3, 7, 14, 21, and 30 days following EPO

Study Arms (2)

EPO

EXPERIMENTAL

Recombinant human erythropoietin (EPO)

Other: Exercise test

Placebo

PLACEBO COMPARATOR

Saline placebo

Other: Exercise test

Interventions

90-minute load carriage exercise test on a treadmill

EPOPlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and premenopausal females ages 18-45 years
  • Physically active

You may not qualify if:

  • Low iron stores (ferritin \<15 mg/mL)
  • Anemia (females: hemoglobin \< 12 g/dL, males: hemoglobin \< 13 g/dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Iron DeficienciesAnemia, Iron-DeficiencyMotor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

April 8, 2026

Study Start

September 1, 2025

Primary Completion

December 31, 2025

Study Completion

May 1, 2026

Last Updated

April 8, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations