Conditions: Prophylaxis of Acute Mountain Sickness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: yes

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.

Arms:
arm 1: Experimental : Acetazolamide 125 mg twice daily arm 2: Experimental: Acetazolamide 62.5 mg twice daily

Interventions: intervention 1: Low Dose Acetazolamide intervention 2: Normal Dose Acetazolamide
Intervention descriptions: intervention 1: Administration of low dose acetazolamide intervention 2: Administration of normal dose acetazolamide

Protocol document: