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

NCT02463357 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2021-03-30

Study results available
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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

Interventions

DIETARY_SUPPLEMENT

Quercetin

DRUG

Nifedipine extended release

DRUG

Methazolamide

DRUG

Metformin

DRUG

Placebo

DRUG

Nitrite

Sponsors & Collaborators

  • Alma College

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Robert Roach, PhD · University of Colorado Anschutz Medical Campus, Altitude Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463357 on ClinicalTrials.gov