- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02463357
Three New Ideas to Protect Special Forces From the Stress of High Altitude
Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance and endurance exercise capacity are impaired. Therefore, the goal of this research is to identify effective pharmacological agents that will help reduce the symptoms of AMS and improve physical and cognitive performance at high altitude.
The investigators will study the efficacy of the dietary supplement, quercetin, the drugs nifedipine (extended release) and methazolamide taken together, the drug metformin, and the drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at high altitudes.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Michigan
-
Alma, Michigan, United States, 48801
- Alma College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy,
- young (18-30 years old) men who can meet APFT requirements for special operation forces (SOF) training as outlined by the US Army (42 push ups, 53 sit-ups, 6 pull-ups, 2 mile run in < 15 min 54 s)
Exclusion Criteria:
- women;
- smokers;
- participants with diseases or disorders known to be affected by hypoxia or the drugs used in this study, such as hypotension, anemia, sickle cell trait or disease, and diabetes;
- participants with a history of significant head injury, migraines or seizures;
- participants taking any medication (over-the-counter or prescription) or herbal supplements;
- participants with known flavonoid allergies;
- participants with known allergies to metformin;
- participants with known hypersensitivity reaction to nifedipine;
- participants with known allergies to sulfonamide-based drugs;
- participants with inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day;
- exposure to high altitude above 1000m in the previous three months; or
- participants who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude);
- participants who are unable to achieve the minimum physical criteria required for SOF training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quercetin
Quercetin: 500mg pill, twice daily for 5 days
|
|
Experimental: Nifedipine+Methazolamide
Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days
|
|
Experimental: Metformin
Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)
|
|
Placebo Comparator: Placebo
Sugar pill manufactured to look like all other investigational products
|
|
Experimental: Nitrite
Nitrite: 20mg pill, three times daily for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Environmental Symptoms Questionnaire at High Altitude
Time Frame: Baseline and during high altitude exposure (3 days, AM/PM)
|
Self-reported assessment of AMS symptoms (headache, lightheaded, dizzy, etc.).
The 11-item Environmental Symptoms Questionnaire measures Acute Mountain Sickness symptoms (nausea, weakness, lightheadedness, dizziness, headache, etc.).
Possible scores range from 0 to 55 (0-5 per item), with higher scores indicating a better outcome.
|
Baseline and during high altitude exposure (3 days, AM/PM)
|
Change in Lake Louise AMS Scoring System at High Altitude
Time Frame: Baseline and during high altitude exposure (3 days, AM/PM)
|
Self-reported assessment of AMS symptoms (headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping).
The Lake Louise AMS Scoring System measures symptoms of altitude sickness.
Possible scores range from 0 to 16, with higher scores indicating a worse outcome.
|
Baseline and during high altitude exposure (3 days, AM/PM)
|
Change in Army Physical Fitness Test (APFT) at High Altitude
Time Frame: Baseline, 1st day at high altitude
|
Timed 2 mile run, push-ups, sit-ups, and pull-ups.
The Army Physical Fitness Test (APFT) measures physical fitness.
Higher scores indicate a better outcome.
A score of 60 is considered minimum "passing" score.
The maximum possible score is 300, indicating the highest level of physical fitness.
|
Baseline, 1st day at high altitude
|
Change in Uphill Hike at High Altitude
Time Frame: 2nd day at altitude
|
Timed 3.1 mile uphill run/hike, with weighted back-pack
|
2nd day at altitude
|
Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time at High Altitude
Time Frame: Baseline and and 1st day at high altitude
|
Battery of nine cognitive function tests.
The Defense Automated Neurobehavioral Assessment (DANA) measures cognitive function and was used to measure mean reaction time.
Possible scores range from 180 to 500 milliseconds, with lower scores indicating a better outcome.
|
Baseline and and 1st day at high altitude
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Roach, PhD, University of Colorado Anschutz Medical Campus, Altitude Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Altitude Sickness
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Protective Agents
- Carbonic Anhydrase Inhibitors
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Antioxidants
- Tocolytic Agents
- Metformin
- Nifedipine
- Quercetin
- Methazolamide
Other Study ID Numbers
- 15-0254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mountain Sickness
-
University of UtahCompletedProphylaxis of Acute Mountain SicknessUnited States
-
China Medical University HospitalChina Medical University, ChinaUnknownAcute Mountain Sickness (AMS)Taiwan
-
Tasly Pharmaceuticals, Inc.RecruitingAcute Mountain Sickness (AMS)United States, China
-
Tasly Pharmaceuticals, Inc.CompletedAcute Mountain Sickness (AMS)United States
-
Robert J Noveck, M.D.United States Department of DefenseCompletedAcute Mountain Sickness and FatigueUnited States
-
University of OregonCompleted
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAcute Mountain SicknessKyrgyzstan
-
Stanford UniversityCompletedAcute Mountain SicknessUnited States
-
University of MontanaCompleted
-
University of Colorado, DenverHimalayan Rescue AssociationNot yet recruitingAcute Mountain SicknessNepal
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States