Effects of intravenous iron on performance at high altitude

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.