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

NCT ID: NCT02463357

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-09-30

Brief 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.

Conditions

Mountain Sickness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Quercetin

Quercetin: 500mg pill, twice daily for 5 days

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DIETARY_SUPPLEMENT

Nifedipine+Methazolamide

Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days

Group Type: EXPERIMENTAL

Nifedipine extended release

Intervention Type: DRUG

Methazolamide

Intervention Type: DRUG

Metformin

Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Placebo

Sugar pill manufactured to look like all other investigational products

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Nitrite

Nitrite: 20mg pill, three times daily for 5 days

Group Type: EXPERIMENTAL

Nitrite

Intervention Type: DRUG

Interventions

Quercetin

Intervention Type: DIETARY_SUPPLEMENT

Nifedipine extended release

Intervention Type: DRUG

Methazolamide

Intervention Type: DRUG

Metformin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Nitrite

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alma College

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Roach, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Anschutz Medical Campus, Altitude Research Center

Locations

Alma College

Alma, Michigan, United States

Countries

United States

Other Identifiers

15-0254

Identifier Type: -

Identifier Source: org_study_id