Trial · NCT02463357

Three New Ideas to Protect Special Forces From the Stress of High Altitude

NCT02463357, Phase 4, Completed, University of Colorado, Denver; results first posted 2021-03-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Three New Ideas to Protect Special Forces From the Stress of High Altitude. Trials, record NCT02463357. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02463357

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Three New Ideas to Protect Special Forces From the Stress of High Altitude
NCT number: NCT02463357
Status: Completed
Phases: Phase 4
Enrollment: 148 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Mountain Sickness
Interventions: Quercetin, Nifedipine extended release, Methazolamide, Metformin, Placebo, Nitrite
First posted: 2015-06-04
Last updated: 2021-03-30
Results first posted: 2021-03-30

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Environmental Symptoms Questionnaire at High Altitude	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.
Primary	Change in Lake Louise AMS Scoring System at High Altitude	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.
Primary	Change in Army Physical Fitness Test (APFT) at High Altitude	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.
Primary	Change in Uphill Hike at High Altitude	2nd day at altitude	Timed 3.1 mile uphill run/hike, with weighted back-pack
Primary	Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time at High Altitude	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Environmental Symptoms Questionnaire at High Altitude	Baseline and during high altitude exposure (3 days, AM/PM)	Two participants who withdrew from the study were not analyzed.	score on a scale	MEAN
PRIMARY	Change in Lake Louise AMS Scoring System at High Altitude	Baseline and during high altitude exposure (3 days, AM/PM)	Two participants who withdrew from the study were not analyzed.	score on a scale	MEAN
PRIMARY	Change in Army Physical Fitness Test (APFT) at High Altitude	Baseline, 1st day at high altitude	Two participants who withdrew from the study were not analyzed.	score on a scale	MEAN
PRIMARY	Change in Uphill Hike at High Altitude	2nd day at altitude	Two participants who withdrew from the study were not analyzed.	seconds	MEAN
PRIMARY	Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time at High Altitude	Baseline and and 1st day at high altitude	Seven participants were not analyzed due to lack of data collection at baseline.	milliseconds	MEAN

Source ClinicalTrials.gov

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Environmental Symptoms Questionnaire at High Altitude	Quercetin	Baseline	0.132	Standard Deviation 0.179	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Nifedipine+Methazolamide	Baseline	0.122	Standard Deviation 0.214	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Metformin	Baseline	0.080	Standard Deviation 0.132	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Placebo	Baseline	0.069	Standard Deviation 0.109	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Nitrite	Baseline	0.121	Standard Deviation 0.240	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Quercetin	Change at 3 days	-0.088	Standard Deviation 0.214	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Nifedipine+Methazolamide	Change at 3 days	-0.073	Standard Deviation 0.224	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Metformin	Change at 3 days	0.128	Standard Deviation 0.425	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Placebo	Change at 3 days	0.035	Standard Deviation 0.184	score on a scale
Change in Environmental Symptoms Questionnaire at High Altitude	Nitrite	Change at 3 days	0.044	Standard Deviation 0.380	score on a scale

1 to 10 of 45Source ClinicalTrials.gov

See all 45 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Quercetin	20
Overall Study	STARTED	Nifedipine+Methazolamide	20
Overall Study	STARTED	Metformin	20
Overall Study	STARTED	Placebo	19
Overall Study	STARTED	Nitrite	20
Overall Study	COMPLETED	Quercetin	19
Overall Study	COMPLETED	Nifedipine+Methazolamide	20
Overall Study	COMPLETED	Metformin	20
Overall Study	COMPLETED	Placebo	19
Overall Study	COMPLETED	Nitrite	19

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anxiety attack	Psychiatric disorders	Quercetin	0	20	0
other	Anxiety attack	Psychiatric disorders	Nifedipine+Methazolamide		20
other	Anxiety attack	Psychiatric disorders	Metformin	1	20	1
other	Anxiety attack	Psychiatric disorders	Placebo	0	19	0
other	Anxiety attack	Psychiatric disorders	Nitrite	0	20	0
other	Dehydration	General disorders	Quercetin	0	20	0
other	Dehydration	General disorders	Nifedipine+Methazolamide		20
other	Dehydration	General disorders	Metformin	1	20	1
other	Dehydration	General disorders	Placebo	1	19	1
other	Dehydration	General disorders	Nitrite	0	20	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Quercetin	0	20
Total, all-cause mortality	Nifedipine+Methazolamide	0	20
Total, all-cause mortality	Metformin	0	20
Total, all-cause mortality	Placebo	0	19
Total, all-cause mortality	Nitrite	0	20
Total, other adverse events	Quercetin	1	20
Total, other adverse events	Nifedipine+Methazolamide	0	20
Total, other adverse events	Metformin	2	20
Total, other adverse events	Placebo	1	19
Total, other adverse events	Nitrite	1	20

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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