Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-11 @ 5:08 PM
Study NCT ID:
NCT01993667
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2013-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Scott.McIntosh@hsc.utah.edu', 'phone': '801-581-2730', 'title': 'Dr. Scott McIntosh, MD, MPH', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 days', 'eventGroups': [{'id': 'EG000', 'title': 'Acetazolamide Normal Dose', 'description': 'Experimental : Acetazolamide 125 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acetazolamide Low Dose', 'description': 'Experimental: Acetazolamide 62.5 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Normal Dose', 'description': 'Experimental : Acetazolamide 125 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}, {'id': 'OG001', 'title': 'Acetazolamide Low Dose', 'description': 'Experimental: Acetazolamide 62.5 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 days', 'description': 'Lake Louise Score, A total score of 3 to 5 indicates mild AMS. A score of 6 or more signifies severe AMS. Minimum value - 0, Maximum = 15', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-three participants had sufficient data to be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Normal Dose', 'description': 'Experimental : Acetazolamide 125 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}, {'id': 'OG001', 'title': 'Acetazolamide Low Dose', 'description': 'Experimental: Acetazolamide 62.5 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 days', 'description': 'The typical side effects of acetazolamide will be measured daily (paresthesias of fingers and toes, change in urination frequency, and change in taste of beverages).\n\nThe side effect questionnaire included the following questions: In the past 12 h, have you experienced the following symptoms: Tingling of toes? Tingling of fingers? Increase in urination? Taste change of beverages? Symptoms were self-reported and rated on a 0-5 scale (0=none, 5=maximum)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These participants had sufficient data to be included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetazolamide Normal Dose', 'description': 'Experimental : Acetazolamide 125 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}, {'id': 'FG001', 'title': 'Acetazolamide Low Dose', 'description': 'Experimental: Acetazolamide 62.5 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Insufficient data to analyze', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Insufficient altitude reached', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetazolamide Normal Dose', 'description': 'Experimental : Acetazolamide 125 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}, {'id': 'BG001', 'title': 'Acetazolamide Low Dose', 'description': 'Experimental: Acetazolamide 62.5 mg twice daily\n\nAcetazolamide: Administration of low dose acetazolamide'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '41.6', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2013-11-12', 'resultsFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-10', 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score', 'timeFrame': '12 days', 'description': 'Lake Louise Score, A total score of 3 to 5 indicates mild AMS. A score of 6 or more signifies severe AMS. Minimum value - 0, Maximum = 15'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Side Effects', 'timeFrame': '12 days', 'description': 'The typical side effects of acetazolamide will be measured daily (paresthesias of fingers and toes, change in urination frequency, and change in taste of beverages).\n\nThe side effect questionnaire included the following questions: In the past 12 h, have you experienced the following symptoms: Tingling of toes? Tingling of fingers? Increase in urination? Taste change of beverages? Symptoms were self-reported and rated on a 0-5 scale (0=none, 5=maximum)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prophylaxis of Acute Mountain Sickness']}, 'descriptionModule': {'briefSummary': 'This is a phase 4, randomized, double-blinded interventional trial comparing alternative doses of Acetazolamide for the prevention of High Altitude Illness.', 'detailedDescription': '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.\n\nCurrent 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* English or Indian speaking\n* Mountaineers or trekkers who plan to climb Mt. McKinley or trek to Base Camp on Mt. Everest\n\nExclusion Criteria:\n\n* Low sodium and/potassium blood serum levels\n* Kidney disease or dysfunction\n* Liver disease, dysfunction, or cirrhosis\n* Suprarenal gland failure or dysfunction\n* Hyperchloremic acidosis\n* Angle-closure glaucoma\n* Taking high dose aspirin (over 325 mg/day)\n* Any reaction to sulfa drugs or acetazolamide\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01993667', 'briefTitle': 'Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing', 'orgStudyIdInfo': {'id': '50402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetazolamide normal dose', 'description': 'Experimental : Acetazolamide 125 mg twice daily', 'interventionNames': ['Drug: Normal Dose Acetazolamide']}, {'type': 'EXPERIMENTAL', 'label': 'Acetazolamide low dose', 'description': 'Experimental: Acetazolamide 62.5 mg twice daily', 'interventionNames': ['Drug: Low Dose Acetazolamide']}], 'interventions': [{'name': 'Low Dose Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': 'Administration of low dose acetazolamide', 'armGroupLabels': ['Acetazolamide low dose']}, {'name': 'Normal Dose Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': 'Administration of normal dose acetazolamide', 'armGroupLabels': ['Acetazolamide normal dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Sciences Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'McIntosh Scott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Scott McIntosh', 'investigatorAffiliation': 'University of Utah'}}}}