Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06019858
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in energy levels. [Baseline to Day 30]', 'timeFrame': '30 days', 'description': 'Survey-based assessment (0-5 scale) of participant reported energy levels.'}], 'secondaryOutcomes': [{'measure': 'Change in ability to concentration. [Baseline to Day 30]', 'timeFrame': '30 days', 'description': 'Survey-based assessment (0-5 scale) of participant reported concentration abilities.'}, {'measure': 'Change in participant-perceived productivity. [Baseline to Day 30]', 'timeFrame': '30 days', 'description': 'Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.'}, {'measure': 'Changes in mood. [Baseline to Day 30]', 'timeFrame': '30 days', 'description': 'Survey-based assessment (0-5 scale) of mood.'}, {'measure': 'Changes in brain fog. [Baseline to Day 30]', 'timeFrame': '30 days', 'description': 'Survey-based assessment (0-5 scale) of brain fog experienced by participants.'}, {'measure': 'Change in body weight. [Baseline to Day 30]', 'timeFrame': '30 days', 'description': 'Participants will weight themselves at baseline and endline and provide their body weight.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Energy', 'Fatigue', 'Mood', 'Weight Loss', 'Cognition']}, 'descriptionModule': {'briefSummary': "This is a virtual, single-arm clinical trial that will last 30 days. Participants will drink 1 bottle of the Vitamin Energy® shot daily and complete questionnaires at baseline, Day 7, Day 14, and Day 30.\n\nParticipants' energy, mood, and cognitive function will be evaluated at baseline and at each check-in. Bodyweight will also be assessed at baseline and Day 30. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nMen and women 18 years and over\n\nSelf-reported issues with:\n\n* Energy\n* Focus\n* Brain fog Participants who often feel fatigued Willing to maintain the same caffeine consumption during the study period Generally healthy - don't live with any uncontrolled chronic disease\n\nExclusion Criteria:\n\nAny pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.\n\nAnyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant Unwilling to follow the study protocol."}, 'identificationModule': {'nctId': 'NCT06019858', 'briefTitle': 'A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vitamin Energy®'}, 'officialTitle': 'A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels', 'orgStudyIdInfo': {'id': '20348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin Energy Shot', 'description': 'Participants will take one bottle daily of the Vitamin Energy® shot, in the morning.', 'interventionNames': ['Other: Vitamin Energy Shot']}], 'interventions': [{'name': 'Vitamin Energy Shot', 'type': 'OTHER', 'description': 'Vitamin Energy® shot is a naturally-caffeinated functional energy shot that contains:\n\nVitamin B3 Vitamin B6 Vitamin B12 Natural Caffeine (green tea extract) L-Carnitine Tartrate Potassium Sorbate Taurine Sucralose', 'armGroupLabels': ['Vitamin Energy Shot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitamin Energy®', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}