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

Primary Purpose

Mountain Sickness

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quercetin
Nifedipine extended release
Methazolamide
Metformin
Placebo
Nitrite
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mountain Sickness focused on measuring Exercise, Aerobic, Cognitive Function

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Alma College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Quercetin

Nifedipine+Methazolamide

Metformin

Placebo

Nitrite

Arm Description

Quercetin: 500mg pill, twice daily for 5 days

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

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

Sugar pill manufactured to look like all other investigational products

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

Outcomes

Primary Outcome Measures

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.
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.
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.
Change in Uphill Hike at High Altitude
Timed 3.1 mile uphill run/hike, with weighted back-pack
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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2015
Last Updated
March 4, 2021
Sponsor
University of Colorado, Denver
Collaborators
Alma College
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1. Study Identification

Unique Protocol Identification Number
NCT02463357
Brief Title
Three New Ideas to Protect Special Forces From the Stress of High Altitude
Official Title
Three New Ideas to Protect Special Forces From the Stress of High Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Alma College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mountain Sickness
Keywords
Exercise, Aerobic, Cognitive Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quercetin
Arm Type
Experimental
Arm Description
Quercetin: 500mg pill, twice daily for 5 days
Arm Title
Nifedipine+Methazolamide
Arm Type
Experimental
Arm Description
Nifedipine extended release: 30mg pill, twice daily for 5 days; Methazolamide: 125mg pill, twice daily for 5 days
Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar pill manufactured to look like all other investigational products
Arm Title
Nitrite
Arm Type
Experimental
Arm Description
Nitrite: 20mg pill, three times daily for 5 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin
Intervention Type
Drug
Intervention Name(s)
Nifedipine extended release
Intervention Type
Drug
Intervention Name(s)
Methazolamide
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Nitrite
Primary Outcome Measure Information:
Title
Change in Environmental Symptoms Questionnaire at High Altitude
Description
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.
Time Frame
Baseline and during high altitude exposure (3 days, AM/PM)
Title
Change in Lake Louise AMS Scoring System at High Altitude
Description
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.
Time Frame
Baseline and during high altitude exposure (3 days, AM/PM)
Title
Change in Army Physical Fitness Test (APFT) at High Altitude
Description
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.
Time Frame
Baseline, 1st day at high altitude
Title
Change in Uphill Hike at High Altitude
Description
Timed 3.1 mile uphill run/hike, with weighted back-pack
Time Frame
2nd day at altitude
Title
Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time at High Altitude
Description
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.
Time Frame
Baseline and and 1st day at high altitude

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Roach, PhD
Organizational Affiliation
University of Colorado Anschutz Medical Campus, Altitude Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alma College
City
Alma
State/Province
Michigan
ZIP/Postal Code
48801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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