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Intravenous Iron for Performance at High Altitude

This study is looking at whether an intravenous (IV) iron treatment called Injectafer can help people perform better at high altitudes. Researchers want to see if Injectafer improves the amount of oxygen in your blood and your performance on a 2-mile treadmill test compared to a placebo (a saline injection with no active medicine). They will test this at sea level and at a simulated high altitude (about 15,750 feet). They are looking for healthy men and women between 18 and 40 years old who are physically active. The study aims to enroll 24 participants and is currently unclear about its recruitment status.

Study design
This is a double-blind, randomized study, meaning neither you nor the researchers will know if you receive Injectafer or a placebo. It plans to include 24 participants.
What's involved
You would have seven study visits, including body scans, breathing tests, exercise tests, and blood draws. You would also receive either the iron or placebo injection during one visit.
Compensation
Not stated in the trial record.
Follow-up
Your performance will be assessed one week and two weeks after receiving the intervention at high altitude.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06686693

Intravenous Iron Effects on Performance at High Altitude

Recruiting
PHASE4Ages 18–40Interventional
United States Army Research Institute of Environmental Medicine
~24 participants
Updated 2025-03-30 on ClinicalTrials.gov
What's tested:InjectaferPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2 mile treadmill time trial performance
Measured over Baseline at sea level, pre intervention at altitude, one week post intervention at altitude, and two weeks post intervention at altitude.

Conditions

Hypoxia

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Hypoxia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Roy Salgado, PhD · PRINCIPAL_INVESTIGATOR · United States Army Research Institute of Environmental Medicine

Who to contact

Roy Salgado, PhD
[email protected]
508-206-2375
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Man or woman, age 18-40 years
BMI 18.5-30 kg/m2
In good health as determined by the Office of Medical Support \& Oversight (OMSO) General Medical Clearance
Passed his/her most recent Army Combat Fitness Test (ACFT) (Military Volunteers Only) or exercises at least 2 times per week and able to complete two mile run in ≤ 21 minutes (Civilian Volunteers)
Willing to not exercise, or drink alcoholic/caffeinated beverages 24 hours prior to each testing session
Willing to not perform any strenuous exercise 36 hours prior to each testing session

Exclusion

Women who are pregnant or planning to become pregnant during the study
Taking prescription medication, or over-the-counter medications other than contraceptives, unless approved by OMSO \& PI
Taking dietary supplements unless approved by OMSO \& PI
Born at altitudes greater than 2,100 m (7,000 ft)
Living in areas that are more than 1,200 m (4,000 ft) or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)
Musculoskeletal injuries that compromise the ability to walk/run on a treadmill
Presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)
Hemoglobin concentration: men: Hb \<13.5 g/dL or Hb \>17.7 g/dL; women Hb \<12.5 g/dL or Hb \>15.9 g/dL
Ferritin \< 50 ng/mL or greater than 150 ng/mL
Any history of malignancy
Personal or family history of blood clots
History of thromboembolic disease, hypertension, and known risk factors of cardiovascular disease
Blood donation within 8 weeks of beginning the study
History of seizures
History of inflammatory bowel disease
Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)
Abnormal PT/PTT test or problems with blood clotting
Any nicotine or recreational drug use (unless quit \> 1 month prior to study orientation)
Presence of respiratory tract infections (\< 1 month prior)
Experience recent cold, coughs, or sinus infections (\< 2 weeks prior)
Allergy to skin adhesive
Evidence of apnea or sleeping disorder
Present condition of alcoholism, use of anabolic steroids, other substance abuse issues
Body mass \<50 kg (110.5 lbs)
History of hyperparathyroidism
History of vitamin D deficiency
History of systemic inflammatory disease (rheumatoid arthritis, lupus erythematosus)
Any drug allergies
History of hypersensitivity reaction
History of asthma
History of kidney or liver disease
Any previous intravenous iron injection

What this trial measures

  • 2 mile treadmill time trial performanceBaseline at sea level, pre intervention at altitude, one week post intervention at altitude, and two weeks post intervention at altitude.

    Time to complete self-paced 2 miles treadmill time trial (min:sec)