Mountain SicknessPhase 4NCT02463357

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

A Phase 4 study testing Quercetin, Nifedipine extended release and Methazolamide in people with Mountain Sickness, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Mountain Sickness
What is being tested?: Quercetin, Nifedipine extended release and Methazolamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 148 participants
Where: 1 siteUnited States
Study dates: Aug 2015to Sep 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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;

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Alma College
Alma, Michigan, 48801

Other trials in United States

About this study

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.

Conditions: Mountain Sickness
Being tested: Quercetin, Nifedipine extended release, Methazolamide, Metformin, Placebo
Keywords: Exercise, Aerobic, Cognitive Function
Medical subject headings: Altitude Sickness, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuercetinDietary supplement
Nifedipine extended releaseDrug
MethazolamideDrug
MetforminDrug
PlaceboDrug
NitriteDrug

Study groups in NCT02463357
Study group	Role	What they receive
Quercetin	Experimental	Quercetin: 500mg pill, twice daily for 5 days Receives: Dietary Supplement: Quercetin
Nifedipine+Methazolamide	Experimental	Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days Receives: Drug: Nifedipine extended release; Drug: Methazolamide
Metformin	Experimental	Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days) Receives: Drug: Metformin
Placebo	Placebo comparator	Sugar pill manufactured to look like all other investigational products Receives: Drug: Placebo
Nitrite	Experimental	Nitrite: 20mg pill, three times daily for 5 days Receives: Drug: Nitrite

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1st day at high altitude
Change in Uphill Hike at High Altitude
Timed 3.1 mile uphill run/hike, with weighted back-pack
Measured: 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.
Measured: Baseline and and 1st day at high altitude

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Sep 2016

First posted4 Jun 2015 (estimated)
Study startAug 2015
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mountain SicknessStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02463357
Sponsor's protocol ID: 15-0254
Status last verified: Mar 2021
First submitted: 29 May 2015
Last updated: 30 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
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Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
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All Mountain Sickness trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Three New Ideas to Protect Special Forces From the Stress of High Altitude
ClinicalTrials.gov ID: NCT02463357
Acronym / sponsor ID: 15-0254
Conditions: Mountain Sickness
Keywords: Exercise, Aerobic, Cognitive Function
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Alma College
Study start: Aug 2015 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 4 Jun 2015 (estimated)
Results: Posted 30 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Quercetin	Experimental	Dietary Supplement: QuercetinQuercetin: 500mg pill, twice daily for 5 days
Nifedipine+Methazolamide	Experimental	Drug: Nifedipine extended release, Drug: MethazolamideNifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days
Metformin	Experimental	Drug: MetforminMetformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)
Placebo	Placebo comparator	Drug: PlaceboSugar pill manufactured to look like all other investigational products
Nitrite	Experimental	Drug: NitriteNitrite: 20mg pill, three times daily for 5 days

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quercetin	Dietary supplement	Quercetin
Nifedipine extended release	Drug	Nifedipine+Methazolamide
Methazolamide	Drug	Nifedipine+Methazolamide
Metformin	Drug	Metformin
Placebo	Drug	Placebo
Nitrite	Drug	Nitrite

Primary outcome

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.
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.
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.
Change in Uphill Hike at High Altitude
Time frame: 2nd day at altitude
Timed 3.1 mile uphill run/hike, with weighted back-pack
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.

Results and safety

Results posted to the registry on 30 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quercetin	20	19
Nifedipine+Methazolamide	20	20
Metformin	20	20
Placebo	19	19
Nitrite	20	19

Primary outcome: Change in Environmental Symptoms Questionnaire at High Altitude

Time frame: Baseline and during high altitude exposure (3 days, AM/PM). Mean (Standard Deviation). Unit: score on a scale

Measure	Quercetin n = 19	Nifedipine+Methazolamide n = 19	Metformin n = 20	Placebo n = 19	Nitrite n = 20
Baseline	0.132 (0.179)	0.122 (0.214)	0.080 (0.132)	0.069 (0.109)	0.121 (0.240)
Change at 3 days	-0.088 (0.214)	-0.073 (0.224)	0.128 (0.425)	0.035 (0.184)	0.044 (0.380)

Population analysed: Two participants who withdrew from the study were not analyzed.

Primary outcome: Change in Lake Louise AMS Scoring System at High Altitude

Time frame: Baseline and during high altitude exposure (3 days, AM/PM). Mean (Standard Deviation). Unit: score on a scale

Measure	Quercetin n = 19	Nifedipine+Methazolamide n = 19	Metformin n = 20	Placebo n = 19	Nitrite n = 20
Baseline	0.00 (0.00)	0.150 (0.489)	0.150 (0.671)	0.00 (0.00)	0.250 (1.118)
Change at Day 3	0.053 (0.229)	0.150 (0.875)	0.750 (2.124)	0.632 (1.012)	0.474 (1.896)

Population analysed: Two participants who withdrew from the study were not analyzed.

Primary outcome: Change in Army Physical Fitness Test (APFT) at High Altitude

Time frame: Baseline, 1st day at high altitude. Mean (Standard Deviation). Unit: score on a scale

Measure	Quercetin n = 19	Nifedipine+Methazolamide n = 19	Metformin n = 20	Placebo n = 19	Nitrite n = 20
Baseline	247.2 (25.1)	251.0 (29.4)	254.1 (26.9)	251.5 (23.9)	252.1 (24.9)
Change at Day 1	-27.5 (23.1)	-59.2 (22.7)	-32.9 (20.5)	-23.0 (27.0)	-26.1 (20.3)

Population analysed: Two participants who withdrew from the study were not analyzed.

Primary outcome: Change in Uphill Hike at High Altitude

Time frame: 2nd day at altitude. Mean (Standard Deviation). Unit: seconds

Measure	Quercetin n = 19	Nifedipine+Methazolamide n = 19	Metformin n = 20	Placebo n = 19	Nitrite n = 20
Value	4685 (364.4)	4993 (595.4)	5005 (975.9)	4819 (685.1)	4953 (670.5)

Population analysed: Two participants who withdrew from the study were not analyzed.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quercetin	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Nifedipine+Methazolamide	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Metformin	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Placebo	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
Nitrite	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Mountain Sickness

Not yet recruiting
High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children High-altitude Pulmonary Edema
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Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
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Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Roach, PhD principal investigator

University of Colorado Anschutz Medical Campus, Altitude Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Quercetin, Nifedipine extended release and Methazolamide in people with Mountain Sickness, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Environmental Symptoms Questionnaire at High Altitude (time frame: Baseline and during high altitude exposure (3 days, AM/PM)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02463357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.