- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517562
The Effects of Acute Erythropoietin on Hepcidin and Dietary Iron Absorption Following Military-relevant Exercise in Energy Deficit: Pilot Study (IRON BOOST)
April 1, 2026 updated by: Pennington Biomedical Research Center
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- LSU Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Males and premenopausal females ages 18-45 years
- Physically active
Exclusion Criteria:
- Low iron stores (ferritin <15 mg/mL)
- Anemia (females: hemoglobin < 12 g/dL, males: hemoglobin < 13 g/dL)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Saline placebo
|
90-minute load carriage exercise test on a treadmill
|
|
Experimental: EPO
Recombinant human erythropoietin (EPO)
|
90-minute load carriage exercise test on a treadmill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional iron absorption
Time Frame: 14 days post-exercise
|
Iron absorption as measured by iron incorporation into red blood cells
|
14 days post-exercise
|
|
Plasma isotope appearance
Time Frame: 0, 30, 60, 90, 120, 180, and 360 minutes post-exercise
|
Plasma iron isotope appearance
|
0, 30, 60, 90, 120, 180, and 360 minutes post-exercise
|
|
Red blood cell iron incorporation
Time Frame: 50 minutes infusion of a stable iron isotope following exercise
|
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
Time Frame: 1, 2, 3, 7, 14, 21, and 30 days following EPO
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
April 1, 2026
First Posted (Actual)
April 8, 2026
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Anemia
- Iron Metabolism Disorders
- Anemia, Hypochromic
- Behavior
- Nutritional and Metabolic Diseases
- Hemic and Lymphatic Diseases
- Iron Deficiencies
- Anemia, Iron-Deficiency
- Motor Activity
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Respiratory Function Tests
- Ergometry
- Exercise Test
Other Study ID Numbers
- 2023-082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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