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| Name | Class |
|---|---|
| Alma College | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quercetin | Experimental | Quercetin: 500mg pill, twice daily for 5 days |
|
| Nifedipine+Methazolamide | Experimental | Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days |
|
| Metformin | Experimental | Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days) |
|
| Placebo | Placebo Comparator | Sugar pill manufactured to look like all other investigational products |
|
| Nitrite | Experimental | Nitrite: 20mg pill, three times daily for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quercetin | Dietary Supplement |
| ||
| Nifedipine extended release |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Environmental Symptoms Questionnaire at High Altitude | 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 | 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 | 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 | 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Roach, PhD | University of Colorado Anschutz Medical Campus, Altitude Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alma College | Alma | Michigan | 48801 | United States |
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49 participants were excluded after consent/enrollment but prior to starting the study because some subjects did not meet baseline criteria, and others had to be excluded due to resource limitations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quercetin | Quercetin: 500mg pill, twice daily for 5 days Quercetin |
| FG001 | Nifedipine+Methazolamide | Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days Nifedipine extended release Methazolamide |
| FG002 | Metformin | Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days) Metformin |
| FG003 | Placebo | Sugar pill manufactured to look like all other investigational products Placebo |
| FG004 | Nitrite | Nitrite: 20mg pill, three times daily for 5 days Nitrite |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quercetin | Quercetin: 500mg pill, twice daily for 5 days Quercetin |
| BG001 | Nifedipine+Methazolamide | Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days Nifedipine extended release Methazolamide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Environmental Symptoms Questionnaire at High Altitude | 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. | Two participants who withdrew from the study were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline and during high altitude exposure (3 days, AM/PM) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quercetin | Quercetin: 500mg pill, twice daily for 5 days Quercetin | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety attack | Psychiatric disorders | Anxiety attack upon arrival at venue (participant had previous history of anxiety) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Roach | University of Colorado Denver | clinicalresearchsupportcenter@ucdenver.edu |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011794 | Quercetin |
| D008704 | Methazolamide |
| D008687 | Metformin |
| D009573 | Nitrites |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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|
| Methazolamide | Drug |
|
| Metformin | Drug |
|
| Placebo | Drug |
|
| Nitrite | Drug |
|
| Baseline and and 1st day at high altitude |
| Withdrawal by Subject |
|
| BG002 | Metformin | Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days) Metformin |
| BG003 | Placebo | Sugar pill manufactured to look like all other investigational products Placebo |
| BG004 | Nitrite | Nitrite: 20mg pill, three times daily for 5 days Nitrite |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days Nifedipine extended release Methazolamide |
| OG002 | Metformin | Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days) Metformin |
| OG003 | Placebo | Sugar pill manufactured to look like all other investigational products Placebo |
| OG004 | Nitrite | Nitrite: 20mg pill, three times daily for 5 days Nitrite |
|
|
| Primary | Change in Lake Louise AMS Scoring System at High Altitude | 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. | Two participants who withdrew from the study were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline and during high altitude exposure (3 days, AM/PM) |
|
|
|
| Primary | Change in Army Physical Fitness Test (APFT) 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. | Two participants who withdrew from the study were not analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1st day at high altitude |
|
|
|
| Primary | Change in Uphill Hike at High Altitude | Timed 3.1 mile uphill run/hike, with weighted back-pack | Two participants who withdrew from the study were not analyzed. | Posted | Mean | Standard Deviation | seconds | 2nd day at altitude |
|
|
|
| Primary | Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time 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. | Seven participants were not analyzed due to lack of data collection at baseline. | Posted | Mean | Standard Deviation | milliseconds | Baseline and and 1st day at high altitude |
|
|
|
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Nifedipine+Methazolamide | Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days Nifedipine extended release Methazolamide | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Metformin | Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days) Metformin | 0 | 20 | 0 | 20 | 2 | 20 |
| EG003 | Placebo | Sugar pill manufactured to look like all other investigational products Placebo | 0 | 19 | 0 | 19 | 1 | 19 |
| EG004 | Nitrite | Nitrite: 20mg pill, three times daily for 5 days Nitrite | 0 | 20 | 0 | 20 | 1 | 20 |
|
| Dehydration | General disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| URI/ILI (Flu-like illness) | Infections and infestations |
|
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| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D009608 | Nitrous Acid |
| D017672 | Nitrogen Compounds |
| Change at Day 3 |
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| Change at Day 1 |
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| Change from baseline at day 1 |
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