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NCT Number: NCT01418157

A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent

Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. There are no randomized controlled trials that have studied protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter.

This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations.

This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be the first RCT done in this issue.

The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.

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Key information

Conditions

Acute Mountain Sickness Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oxford University Clinical Research Unit Nepal

Kathmandu, Nepal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nepalese national
  • Aged 18 to 65
  • Travelling directly from Dhunche to Gosainkunda
  • Rapid ascent as defined by ascent within 3 days

Exclusion criteria

  • Use of any drugs for the prevention of altitude sickness or headache
  • Current illness
  • Current altitude sickness (more than one mild symptom on the Lake Louise Questionnaire (LLQ), or oxygen saturation less than 75%
  • Known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days
  • One night within the last 30 days spent at an altitude of 4500 metres or above
  • Residents of altitude more than 2500m
  • A known drug allergy to sulfonamides.
  • Treatment with any of the following in the last 2 days: acetazolamide (Diamox®), steroids (dexamethasone/decadron, prednisone), theophylline or diuretics (Lasix®), ibuprofen/motrin, naprosyn/naproxen, aspirin or acetaminophen.
  • Any serious intracranial abnormalities such as history of brain tumours or pseudotumour cerebri
  • Known severe uncontrolled headache syndrome
  • Diagnosed renal function impairment, diabetes, cirrhosis of liver or liver dysfunction

Treatment and study plan

Acetazolamide

Drug

125 mg twice daily until 4380 meters altitude

Placebo

Drug

Twice daily

Primary outcomes

  1. Diagnosis of acute mountain sickness

    Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day

    A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.

  2. Diagnosis of acute mountain sickness

    Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days

    A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.

Secondary outcomes

  1. Blood oxygen saturation

    Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day

    Percent

  2. Heart rate

    Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day

    Beats per minute

  3. High altitude headache

    Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day

    High altitude headache severity will be scored in milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.

  4. Blood oxygen saturation

    Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days

    Percent

  5. Heart rate

    Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days

    Beats per minute

  6. High altitude headache

    Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days

    High altitude headache severity will be scored in millimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • Mountain Medicine Society of Nepal
  • University of Oxford
  • Wellcome Trust

Registry information

Official study title

Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 16, 2011
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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