Effects of intravenous iron on performance at high altitude
Intravenous Iron Prophylaxis for Rapid High Altitude Insertions
This study is testing whether getting intravenous iron can help people perform better and breathe easier when exercising at high altitudes compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | United States Army Research Institute of Environmental Medicine Federal |
| Locations | 1 site (Natick, Massachusetts) |
| Trial ID | NCT06686693 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of intravenous iron treatment to a placebo on arterial oxygen saturation and exercise performance during acute exposure to high altitude conditions. Participants will undergo a series of assessments, including a treadmill time trial and blood tests, to evaluate the impact of iron on their physical performance and oxygen levels. The study employs a double-blind, randomized design with 24 participants, half receiving iron and half receiving saline. The effects will be measured at rest and during exercise, both immediately after treatment and two weeks later.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18-40 with a BMI between 18.5 and 30 who can complete a two-mile run in 21 minutes or less.
Not a fit: Patients who are pregnant, taking certain medications, or have lived at high altitudes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance physical performance and oxygen delivery in individuals exposed to high altitude conditions.
How similar studies have performed: While similar studies on iron supplementation exist, this specific approach to high altitude performance enhancement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Natick, Massachusetts
- Usariem — Natick, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Roy Salgado, PhD — United States Army Research Institute of Environmental Medicine
- Study coordinator: Roy Salgado, PhD
- Email: roy.m.salgado.civ@health.mil
- Phone: 508-206-2375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.