Sickness Evaluation at Altitude With Acetazolamide at Relative Dosages

NCT03424226 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 44765
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This double blind randomized trial will compare acetazolamide taken the morning of ascent to acetazolamide taken the evening prior to ascent for the prevention of acute mountain sickness (AMS). The day of ascent dosing has not been studied as a powered primary outcome. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California

Conditions

Acute Mountain Sickness

Outcome Measures

Primary Outcomes (1)

• incidence of acute mountain sickness

  incidence of acute mountain sickness by Lake Louise Questionnaire

  2 days

Study Arms (2)

day of acetazolamide

EXPERIMENTAL

acetazolamide 125mg twice a day, started morning of ascent

Drug: Acetazolamide

night before acetazolamide

ACTIVE COMPARATOR

acetazolamide 125mg twice a day, started evening before ascent

Drug: Acetazolamide

Interventions

Acetazolamide DRUG

a diuretic and commonly used medication for prevention and treatment of acute mountain sickness

Also known as: diamox

day of acetazolamide; night before acetazolamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 healthy non-pregnant volunteer
• live at low elevation \< 4000 ft
• Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
• Available for full study duration (Friday PM-Sunday AM)

You may not qualify if:

• Age \<18 or \>75, Pregnant, Live at altitude \>4000 ft Slept at altitude \> 4000ft within 1 week of study Allergic to acetazolamide, sulfa drugs, Taking non-steroidal anti-inflammatory drugs, Acetazolamide, or Corticosteroids 1 week prior to study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Visually identical pills
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Emergency Medicine, Stanford University

Model Details: Double blind randomized controlled trial

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: August 4, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)