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New treatment option for Hypoxia
Official title Intravenous Iron Effects on Performance at High Altitude
ClinicalTrials.gov ID: NCT06686693
What this study is testing
What is Injectafer?
Injectafer is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypoxia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To compare the effects of IV iron versus placebo (saline) injection on arterial oxygen saturation, submaximal exercise responses, and 2-mile treadmill time-trial performance during acute exposure to hypobaric hypoxia (430 mmHg, simulating \~4800m) assessed 1 and 14 days after treatment. Primary Hypothesis 1: IV iron treatment will improve arterial oxygen saturation at rest and during exercise in acute hypobaric hypoxia and this effect will persist for 2 weeks Primary Hypothesis 2) IV iron treatment will improve 2-mile treadmill time trial performance in acute hypobaric hypoxia and this effect will persist for 2 weeks
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Willing to not exercise, or drink alcoholic/caffeinated beverages 24 hours prior to each testing session
You likely can't join if
- 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...
- Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)
See the full eligibility 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
- 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 \ 17.7 g/dL; women 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
The study team makes the final eligibility decision.
Where it's taking place
- Natick, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Natick, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.