Clinical trial NCT01993667: Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Official title: Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prophylaxis of Acute Mountain Sickness
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.

Detailed description: Acetazolamide, or Diamox, is the standard medical prophylaxis agent for high altitude illness. The medication is effective in preventing acute mountain sickness (AMS), high altitude pulmonary edema (HAPE), and high altitude cerebral edema (HACE). Its mechanism is via inhibition of the carbonic anhydrase enzyme which counteracts the respiratory alkalosis which occurs during ascent to altitude. It facilitates the excretion of bicarbonate in the urine. As a result, acetazolamide hastens acclimatization and helps prevent high altitude disorders.

Current recommended dosing is 125 mg, orally twice daily, started 24 hours prior to ascending in elevation. Side effects include tingling of the fingers and toes and perioral numbness which may be erroneously interpreted as stroke symptoms. Since acetazolamide is a mild diuretic, frequent micturition may occur leading to interruption of daytime activities as well as broken sleep. These effects can affect safety at high altitude. Acetazolamide is normally discontinued 2 days after the user has reached their highest elevation or a plateau in elevation.

A lower dose may be just as effective in preventing high altitude illnesses while preventing the disconcerting side effects resulting from its use. A smaller dose has not been studied, however. We will compare the common dose of 125 mg twice daily with a lower dose of 62.5 mg twice daily.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English or Indian speaking
* Mountaineers or trekkers who plan to climb Mt. McKinley or trek to Base Camp on Mt. Everest

Exclusion Criteria:

* Low sodium and/potassium blood serum levels
* Kidney disease or dysfunction
* Liver disease, dysfunction, or cirrhosis
* Suprarenal gland failure or dysfunction
* Hyperchloremic acidosis
* Angle-closure glaucoma
* Taking high dose aspirin (over 325 mg/day)
* Any reaction to sulfa drugs or acetazolamide
* Pregnant or lactating women

Primary outcomes:
measure: Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score
timeFrame: 12 days
Secondary outcomes:
measure: Number of Participants With Side Effects
timeFrame: 12 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: McIntosh Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: