[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568858":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"United States Army Research Institute of Environmental Medicine","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","EXPERIMENTAL","Placebo - saline",[13],"Other: Placebo",{"label":15,"type":10,"description":16,"interventionNames":17},"Intravenous iron","Iron - Injectafer 15 mg\u002Fkg up to 1000 mg",[18],"Drug: Injectafer",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Injectafer","Injectafer - 15 mg\u002Fkg up to 1000 mg",[15],null,{"type":27,"name":9,"description":9,"armGroupLabels":28,"otherNames":25},"OTHER",[9],[30],{"name":31,"affiliation":5,"role":32},"Roy Salgado, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","508-206-2375","roy.m.salgado.civ@health.mil",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"USARIEM","RECRUITING","Natick","Massachusetts","01760","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.3495,42.28343,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":36,"phoneExt":25,"email":56},"Roy M Salgado, Ph.D.","roy.m.salgado.civ@mail.mil",{"type":32,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Roy Salgado","Principal Investigator","100568858","phase-4-intravenous-iron-effects-on-performance-at-high-altitude-100568858",false,"NCT06686693","Intravenous Iron Effects on Performance at High Altitude","Intravenous Iron Prophylaxis for Rapid High Altitude Insertions","Inclusion Criteria:\n\n* Man or woman, age 18-40 years\n\n  * BMI 18.5-30 kg\u002Fm2\n  * In good health as determined by the Office of Medical Support \\& Oversight (OMSO) General Medical Clearance\n  * Passed his\u002Fher 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)\n  * Willing to not exercise, or drink alcoholic\u002Fcaffeinated beverages 24 hours prior to each testing session\n  * Willing to not perform any strenuous exercise 36 hours prior to each testing session\n\nExclusion Criteria:\n\n* Women who are pregnant or planning to become pregnant during the study\n\n  * Taking prescription medication, or over-the-counter medications other than contraceptives, unless approved by OMSO \\& PI\n  * Taking dietary supplements unless approved by OMSO \\& PI\n  * Born at altitudes greater than 2,100 m (7,000 ft)\n  * 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\n  * Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)\n  * Musculoskeletal injuries that compromise the ability to walk\u002Frun on a treadmill\n  * Presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)\n  * Hemoglobin concentration: men: Hb \\\u003C13.5 g\u002FdL or Hb \\>17.7 g\u002FdL; women Hb \\\u003C12.5 g\u002FdL or Hb \\>15.9 g\u002FdL\n  * Ferritin \\\u003C 50 ng\u002FmL or greater than 150 ng\u002FmL\n  * Any history of malignancy\n  * Personal or family history of blood clots\n  * History of thromboembolic disease, hypertension, and known risk factors of cardiovascular disease\n  * Blood donation within 8 weeks of beginning the study\n  * History of seizures\n  * History of inflammatory bowel disease\n  * Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)\n  * Abnormal PT\u002FPTT test or problems with blood clotting\n  * Any nicotine or recreational drug use (unless quit \\> 1 month prior to study orientation)\n  * Presence of respiratory tract infections (\\\u003C 1 month prior)\n  * Experience recent cold, coughs, or sinus infections (\\\u003C 2 weeks prior)\n  * Allergy to skin adhesive\n  * Evidence of apnea or sleeping disorder\n  * Present condition of alcoholism, use of anabolic steroids, other substance abuse issues\n  * Body mass \\\u003C50 kg (110.5 lbs)\n  * History of hyperparathyroidism\n  * History of vitamin D deficiency\n  * History of systemic inflammatory disease (rheumatoid arthritis, lupus erythematosus)\n  * Any drug allergies\n  * History of hypersensitivity reaction\n  * History of asthma\n  * History of kidney or liver disease\n  * Any previous intravenous iron injection",true,"ALL","18 Years","40 Years",{"count":72,"type":73},24,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","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.\n\nPrimary 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\n\nPrimary 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",[79],"Hypoxia","2025-03-25",{"date":82,"type":83},"2025-03-30","ACTUAL",{"date":85,"type":83},"2022-04-15",{"date":87,"type":73},"2025-09-30",{"name":5,"class":6},1]