Intravenous Iron Effects on Performance at High Altitude

Launched by UNITED STATES ARMY RESEARCH INSTITUTE OF ENVIRONMENTAL MEDICINE · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether intravenous (IV) iron treatment can help improve how well people breathe and perform physical activities when exposed to high altitudes, where the air is thinner and can make it harder to get enough oxygen. Researchers will compare the effects of IV iron to a placebo (a harmless saline solution) on participants' oxygen levels, exercise responses, and their performance on a treadmill test. The trial will assess these effects both 1 day and 14 days after the treatment.

To join the study, participants need to be between 18 and 40 years old, in good health, and able to run two miles in under 21 minutes. They should not have any serious health conditions, recent illnesses, or certain medical histories that could interfere with the trial. Participants will not be allowed to exercise or consume alcohol or caffeine for a day before testing sessions. If you are looking for a way to contribute to research on improving performance at high altitudes, this study might be an excellent opportunity!

Gender

ALL

Eligibility 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