HypoxiaPhase 4NCT06686693
Intravenous Iron Effects on Performance at High Altitude
A Phase 4 study testing Injectafer in people with Hypoxia, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Injectafer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
USARIEM
Natick, Massachusetts, 01760
Roy M Salgado, Ph.D., 508-206-2375, roy.m.salgado.civ@mail.mil
About this study
Official title: Intravenous Iron Prophylaxis for Rapid High Altitude Insertions
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
Read the detailed description
This study will use a double-blind randomized study design in which one group will receive iron (n = 12; Injectafer, 15 mg/kg up to 1000 mg) and the other a placebo (n = 12; saline). Twenty-four participants will complete seven study visits: Visit 1: Orientation visit consisting of dual-energy X-ray absorptiometry scan (DEXA), pulmonary function test, assessment of peak aerobic capacity (VO2peak); Visits 2-3: familiarization consisting of exercise battery (20 minutes of walking followed by 2 mile treadmill time trial); Visits 4, 6-7: high altitude trial (4,800 m) in which skin blood flow during rest will be measured, ventilation at sea level and altitude will be assessed, collection of sea level and altitude arterialized capillary and venous blood will be collected, and the exercise battery. Visit 5: participants will receive the iron or placebo.
- Conditions
- Hypoxia
- Being tested
- Injectafer, Placebo
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectaferDrug
Injectafer - 15 mg/kg up to 1000 mg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo - saline Receives: Other: Placebo |
| Intravenous iron | Experimental | Iron - Injectafer 15 mg/kg up to 1000 mg Receives: Drug: Injectafer |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 mile treadmill time trial performance
Time to complete self-paced 2 miles treadmill time trial (min:sec)
Measured: Baseline at sea level, pre intervention at altitude, one week post intervention at altitude, and two weeks post intervention at altitude.
Secondary outcomes (14)
Ventilation rate
Ventilation rate will be assessed using a pneumotachometer (l/min).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Percent body fat
Percent body fat will be assessed using Dual Energy X-ray Absorptiometry (%body fat).
Measured: Will be assessed once at the beginning of the study.
Oxygen Saturation
Oxygen saturation will be assessed using a finger pulse oximeter (%).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Hematocrit
Hematocrit will be assessed using manual hematocrit method (%).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Ferritin
Ferritin will be assessed using an ELISA (ng/ml).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
C-reactive protein
C-reactive protein will be assessed using an ELISA (mg/L).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Soluble transferrin
Soluble transferrin will be assessed using an ELISA (mg/L).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary PO2
Arterialized capillary PO2 will be assessed using a blood gas analyzer (mmHg).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary PCO2
Arterialized capillary PCO2 will be assessed using a blood gas analyzer (mmHg).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary pH
Arterialized capillary pH will be assessed using a blood gas analyzer.
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Skin Blood flow
Skin blood flow will be assessed via laser doppler (arbitrary units).
Measured: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
VO2peak
Peak aerobic capacity will be assessed using a metabolic cart (ml/kg/min and or l/min).
Measured: Will be assessed once on day 1.
Pulmonary function test
Pulmonary function test will be performed to determine forced vital capacity (FVC; L) using a metabolic cart.
Measured: Will be assessed once on day 1.
Pulmonary function test
Pulmonary function test will be performed to determine forced expired volume in one second (FEV1; L) using a metabolic cart.
Measured: Will be measured once on day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start15 Apr 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, parallel research study design where one group will receive iron or placebo intravenously.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Roy Salgado, United States Army Research Institute of Environmental Medicine
- Investigators
- Roy Salgado, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686693
- Sponsor's protocol ID
- 21-24HC (M-10949)
- Other IDs
- 000000
- Status last verified
- Mar 2025
- First submitted
- 31 Oct 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron Prophylaxis for Rapid High Altitude Insertions
- ClinicalTrials.gov ID
- NCT06686693
- Acronym / sponsor ID
- 21-24HC (M-10949)
- Conditions
- Hypoxia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will use a double-blind randomized study design in which one group will receive iron (n = 12; Injectafer, 15 mg/kg up to 1000 mg) and the other a placebo (n = 12; saline). Twenty-four participants will complete seven study visits: Visit 1: Orientation visit consisting of dual-energy X-ray absorptiometry scan (DEXA), pulmonary function test, assessment of peak aerobic capacity (VO2peak); Visits 2-3: familiarization consisting of exercise battery (20 minutes of walking followed by 2 mile treadmill time trial); Visits 4, 6-7: high altitude trial (4,800 m) in which skin blood flow during rest will be measured, ventilation at sea level and altitude will be assessed, collection of sea level and altitude arterialized capillary and venous blood will be collected, and the exercise battery. Visit 5: participants will receive the iron or placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, parallel research study design where one group will receive iron or placebo intravenously.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: PlaceboPlacebo - saline |
| Intravenous iron | Experimental | Drug: InjectaferIron - Injectafer 15 mg/kg up to 1000 mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Man or woman, age 18-40 years
Key exclusion criteria (33 listed)
- Women who are pregnant or planning to become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InjectaferInjectafer - 15 mg/kg up to 1000 mg | Drug | Intravenous iron |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
2 mile treadmill time trial performance
Time frame: Baseline 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)
14 secondary outcomes
Ventilation rate
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Percent body fat
Time frame: Will be assessed once at the beginning of the study.
Oxygen Saturation
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Hematocrit
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Ferritin
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
C-reactive protein
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Soluble transferrin
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary PO2
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary PCO2
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Arterialized capillary pH
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
Skin Blood flow
Time frame: Pre intervention at sea level and altitude, one week post intervention at sea level and altitude, and two weeks post intervention at sea level and altitude.
VO2peak
Time frame: Will be assessed once on day 1.
Pulmonary function test
Time frame: Will be assessed once on day 1.
Pulmonary function test
Time frame: Will be measured once on day 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roy Salgado, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Injectafer in people with Hypoxia, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roy Salgado, PhD (508-206-2375, roy.m.salgado.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 mile treadmill time trial performance (time frame: Baseline at sea level, pre intervention at altitude, one week post intervention at altitude, and two weeks post intervention at altitude.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.