CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 148 enrolled
Drug / intervention
Nifedipine extended release +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02463357
NCT02463357Phase 4Completed

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

University of Colorado, Denver·interventional·Posted Jun 4, 2015·Updated Mar 30, 2021

In Brief

A Phase 4 clinical trial evaluating Quercetin, Nifedipine extended release, and 4 other interventions for Mountain Sickness. Completed, enrolled 148 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAlma College

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 4, 2015
Enrollment StartAug 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.1 years ago

Interventions

Quercetindietary

Nifedipine extended releasedrug

Methazolamidedrug

Metformindrug

Placebodrug

Nitritedrug