Phase 4 N=99 Triple-blind Prevention

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

Mountain Sickness

Bottom Line

View on ClinicalTrials.gov: NCT02463357 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Change in Environmental Symptoms Questionnaire at High Altitude — 0.132; 0.122; 0.080; 0.069 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Quercetin (Dietary_supplement); Nifedipine extended release (Drug); Methazolamide (Drug); Metformin (Drug); Placebo (Drug); Nitrite (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: University of Colorado, Denver
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Environmental Symptoms Questionnaire at High Altitude	0.132; 0.122; 0.080; 0.069; 0.121; -0.088	—
PRIMARY Change in Lake Louise AMS Scoring System at High Altitude	0.00; 0.150; 0.150; 0.00; 0.250; 0.053	—
PRIMARY Change in Army Physical Fitness Test (APFT) at High Altitude	247.2; 251.0; 254.1; 251.5; 252.1; -27.5	—
PRIMARY Change in Uphill Hike at High Altitude	4685; 4993; 5005; 4819; 4953	—
PRIMARY Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time at High Altitude	308.0; 302.2; 312.3; 333.9; 310.7; -0.5	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02463357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.