Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT03883503
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2019-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in copeptin levels between the interventions', 'timeFrame': '30 minutes after intervention', 'description': 'Difference in copeptin levels (pmol/l) between moderate beer consumption and moderate beer consumption with additional water and sodium (stock/bouillon) intake at timepoint 1.5 hours.'}], 'secondaryOutcomes': [{'measure': 'Change in copeptin levels between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in copeptin Levels (pmol/l) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the Intervention, comparing the interventions'}, {'measure': 'Change in plasma sodium levels between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in plasma sodium (mmol/l) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Change in urinary sodium levels between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in urinary sodium (mmol/kg) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Change in plasma osmolality levels between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in plasma osmolality (mmol/kg) levels from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Change in urinary osmolality levels between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in urinary osmolality (mmol/kg) levels from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Change in plasma Glucose levels between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in plasma glucose (mmol/l) levels from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Change in biomarkers involved in the sodium-water homeostasis between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in different biomarkers (e.g., Fibroblast growth factor 21, aldosterone, renin, Interleukin 6, Interleukin 8) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours, 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Difference in urinary excretion between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Amount of total urinary excretion (ml) at time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours and 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Change in blood alcohol content between the interventions throughout the observation period of 12 hours', 'timeFrame': 'Observation period of 12 hours', 'description': 'Change in blood alcohol content (°/oo) from baseline to time-point 1 hour, 1.5 hours, 2.5 hours, 4 hours and 12 hours after start of the intervention, comparing the interventions'}, {'measure': 'Difference in Response to lottery Experiment before and after the intervention', 'timeFrame': 'Directly before and 30 minutes after intervention', 'description': 'Change in decision making before and after the intervention, comparing the interventions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Copeptin', 'Salt-water homeostasis'], 'conditions': ['Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'The main interest of this study is to investigate the influence of moderate alcohol consumption (beer) on salt-water homeostasis. Therefore, 10 healthy volunteers will participate in 4 Intervention:\n\n* Beer alone\n* Beer and water\n* Beer and salt (stock/bouillon)\n* Water alone During the study day, copeptin, sodium, osmolality and urinary sodium/osmolality will be measured at 6 timepoints.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n\nExclusion Criteria:\n\n* Any acute or chronic illness\n* History of alcohol dependency\n* Alcohol consumption \\>2 units/day\n* Active nicotine abuse\n* Gluten intolerance\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant\n* Participation in another study with investigational drug within the 30 days preceding and during the present study\n* Enrolment of the investigator, his/her family members, employees and other dependent persons\n* Epileptic seizures within the last year\n* BMI \\<18.5 or ≥25.9kg/m2'}, 'identificationModule': {'nctId': 'NCT03883503', 'briefTitle': 'The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'The Influence of Water and Salt Intake on Copeptin Levels During Moderate Alcohol Consumption - a Pathophysiological Study', 'orgStudyIdInfo': {'id': 'CASCO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beer alone', 'description': 'Consumption of beer (correlated for weight to reach a blood alcohol concentration of 0.8) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.', 'interventionNames': ['Other: Beer 5%o']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Beer and water', 'description': 'Consumption of beer and additional water (correlated for weight to reach a blood alcohol concentration of 0.8, 1/3 of water, 2/3 of beer) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.', 'interventionNames': ['Other: Beer 8.5%o and water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Beer and stock', 'description': 'Consumption of beer and additional stock(correlated for weight to reach a blood alcohol concentration of 0.8, 1/3 of stock, 2/3 of beer) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.', 'interventionNames': ['Other: Beer 8.5%o and stock']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water alone', 'description': 'Consumption of water alone (correlated for weight to reach a blood alcohol concentration of 0.8, 1/3 of stock, 2/3 of beer) during 1 hour. Continues measurement of sodium, osmolality, copeptin, urinary sodium, urinary osmolality over 12 hours.', 'interventionNames': ['Other: Water']}], 'interventions': [{'name': 'Beer 5%o', 'type': 'OTHER', 'description': 'Weight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants', 'armGroupLabels': ['Beer alone']}, {'name': 'Beer 8.5%o and water', 'type': 'OTHER', 'description': 'Weight adjusted beer to reach 0.8 blood alcohol content and water will be given over the time course of 1 hour to the participants', 'armGroupLabels': ['Beer and water']}, {'name': 'Beer 8.5%o and stock', 'type': 'OTHER', 'description': 'Weight adjusted beer to reach 0.8 blood alcohol content and stock will be given over the time course of 1 hour to the participants', 'armGroupLabels': ['Beer and stock']}, {'name': 'Water', 'type': 'OTHER', 'description': 'Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants', 'armGroupLabels': ['Water alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Mirjam Christ-Crain, Prof. Dr. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}