RECRUITING

Intravenous Iron and High Altitude

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Intravenous Iron Prophylaxis for Rapid High Altitude Insertions

Quick Facts

Study Start:2022-04-15

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06686693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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 \<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

Inclusion Criteria

Exclusion 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 \<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

Contacts and Locations

Study Contact

Roy Salgado, PhD

CONTACT

508-206-2375

roy.m.salgado.civ@health.mil

Study Locations (Sites)

USARIEM

Natick, Massachusetts, 01760

United States

Collaborators and Investigators

Sponsor: United States Army Research Institute of Environmental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-15

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2022-04-15

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Hypoxia