Intravenous Iron Effects on Performance at High Altitude
ConditionHypoxia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUnited States Army Research Institute of Environmental Medicine
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Injectafer
DrugInjectafer - 15 mg/kg up to 1000 mg
Placebo
Other interventionPlacebo
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: PlaceboExperimental treatment 1 intervention
Group B: Intravenous ironExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2 mile treadmill time trial performance
Time to complete self-paced 2 miles treadmill time trial (min:sec)
Time frame
Baseline at sea level, pre intervention at altitude, one week post intervention at altitude, and two weeks post intervention at altitude.Secondary outcomes
1
Ventilation rate
Ventilation rate will be assessed using a pneumotachometer (l/min).
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.2
Percent body fat
Percent body fat will be assessed using Dual Energy X-ray Absorptiometry (%body fat).
Time frame
Will be assessed once at the beginning of the study.3
Oxygen Saturation
Oxygen saturation will be assessed using a finger pulse oximeter (%).
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.4
Hematocrit
Hematocrit will be assessed using manual hematocrit method (%).
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov