Intravenous Iron Effects on Performance at High Altitude

NCT06686693 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 21-24HC (M-10949)000000
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• 2 mile treadmill time trial performance

  Time to complete self-paced 2 miles treadmill time trial (min:sec)

  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

  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

  Will be assessed once at the beginning of the study.

• Oxygen Saturation

  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

  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

  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.

Study Arms (2)

Placebo

EXPERIMENTAL

Placebo - saline

Other: Placebo

Intravenous iron

EXPERIMENTAL

Iron - Injectafer 15 mg/kg up to 1000 mg

Drug: Injectafer

Interventions

Injectafer DRUG

Injectafer - 15 mg/kg up to 1000 mg

Intravenous iron

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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

You may not qualify 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 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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roy Salgado, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy Salgado, PhD

CONTACT

508-206-2375; roy.m.salgado.civ@health.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Investigator will be blinded to who receives iron or placebo. A investigator not participating in data collection is responsible for randomly assigning participants to the intervention. The medical care providers will be unblinded to intervention assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a double-blind, parallel research study design where one group will receive iron or placebo intravenously.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 13, 2024
• Study Start: April 15, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (1)