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

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mountain Sickness

Intervention: Quercetin (Dietary Supplement); Nifedipine extended release (Drug); Methazolamide (Drug); Metformin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Robert Roach, PhD, Principal Investigator, Affiliation: University of Colorado Anschutz Medical Campus, Altitude Research Center

Overall contact:
Robert Roach, PhD, Phone: 303-724-1671, Email: robert.roach@ucdenver.edu

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, and the drug metformin in reducing symptoms of AMS and improving cognitive and exercise performance at high altitudes.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Change in Environmental Symptoms Questionnaire at High Altitude

Change in Lake Louise AMS Scoring System at High Altitude

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

Change in Uphill hike at High Altitude

Change in Defense Automated Neurobehavioral Assessment (DANA) at High Altitude

Eligibility

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Male.

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, 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 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

Locations and Contacts

Robert Roach, PhD, Phone: 303-724-1671, Email: robert.roach@ucdenver.edu

Alma College, Alma, Michigan 48801, United States; Recruiting
John E Davis, PhD, Email: davisj@alma.edu
Additional Information

Starting date: August 2015
Last updated: August 11, 2015

Page last updated: August 23, 2015

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