Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-02-03 @ 2:34 AM
Study NCT ID:
NCT03290612
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin C to Reduce Morning Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Vitamin C and Placebo doses will be blinded by the research pharmacy, so that participants and investigators are masked to the identity of the tablet. Data analysis will be blinded to the conditions as well until the completion of the study.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular Endothelial Function', 'timeFrame': 'Approximately three months', 'description': 'Vascular endothelial function will be measured as flow-mediated dilation (FMD). We will measure brachial artery FMD immediately upon awakening in a constant posture following an overnight fast using the standard guidelines and protocol.'}, {'measure': 'Oxidative stress', 'timeFrame': 'Approximately three months', 'description': 'Oxidative stress will be measured as malondialdehyde (MDA) adducts from Ethylenediaminetetraacetic acid (EDTA) plasma. Higher values may indicate increased oxidative stress.'}, {'measure': 'Plasma Vitamin C and Tetrahydrobiopterin', 'timeFrame': 'Approximately three months', 'description': 'We will measure Vitamin C levels in the plasma to ensure that the levels are increased after supplementation, and to control for baseline levels. We will measure tetrahydrobiopterin (BH4) from plasma to test if levels are increased upon administration of Vitamin C.'}], 'secondaryOutcomes': [{'measure': 'Platelet aggregation', 'timeFrame': 'Approximately three months', 'description': 'Platelet aggregation will be measured using Chronolog 560 VS Platelet aggregometer as an indicator of how well blood clots or clumps together. Higher values may indicate increased cardiovascular risk.'}, {'measure': 'Plasminogen activator inhibitor -1', 'timeFrame': 'Approximately three months', 'description': 'Plasminogen activator inhibitor-1 (PAI-1) will be measured from plasma as a blood inflammatory marker. Higher values may indicate increased cardiovascular risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep', 'Vitamin C'], 'conditions': ['Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': 'This study will test the efficacy of Vitamin C to counteract morning cardiovascular (CV) risk markers in a randomized, double blind, placebo controlled crossover pilot study. The participants will also perform morning typical behaviors such as arousal from sleep, change in posture (getting out of bed) and mild intensity physical activity; identical to the stressors encountered in everyday life. Primary dependent variables are markers of cardiovascular risk including vascular endothelial function and oxidative stress.', 'detailedDescription': 'The investigators plan to test the efficacy of Vitamin C to counteract morning cardiovascular (CV) risk markers in a randomized, double blind, placebo controlled crossover pilot study. The participants will also perform morning typical behaviors such as arousal from sleep, change in posture (getting out of bed) and mild intensity physical activity; identical to the stressors encountered in everyday life. This pilot study is in healthy middle aged adults without a history of CV disease.\n\nParticipants will spend two nights in an inpatient hospital suite at Hatfield Research Center. Upon awakening in the morning, they will either ingest Vitamin C or placebo in a randomized order. This will be followed by moderate intensity exercise, recovery, and discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants\n* Normal weight or overweight but not obese (18.5\\<BMI\\<33 kg/m2)\n\nExclusion Criteria:\n\n* History of smoking/tobacco use\n* Current prescription/non-prescription medications or drugs of abuse\n* Acute, chronic, or debilitating medical conditions\n* History of working irregular day and night hours, regular night work, or rotating shift work for the six months prior to the study.'}, 'identificationModule': {'nctId': 'NCT03290612', 'briefTitle': 'Vitamin C to Reduce Morning Cardiovascular Risk', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Chronotherapeutic Use of Vitamin C to Reduce Morning Cardiovascular Risk', 'orgStudyIdInfo': {'id': 'IRB 00017294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C then Placebo', 'description': 'Participants will receive a 1.5g dose of Ascorbic Acid upon wake for the first visit, and a placebo tablet on the second visit.', 'interventionNames': ['Dietary Supplement: Vitamin C', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then Vitamin C', 'description': 'Participants will receive a placebo tablet upon wake for the first visit, and a 1.5g dose of Ascorbic Acid on the second visit.', 'interventionNames': ['Dietary Supplement: Vitamin C', 'Other: Placebo']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ascorbic Acid'], 'description': '1.5g Ascorbic Acid', 'armGroupLabels': ['Placebo then Vitamin C', 'Vitamin C then Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Inactive placebo to mimic 1.5g ascorbic acid.', 'armGroupLabels': ['Placebo then Vitamin C', 'Vitamin C then Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Saurabh S Thosar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Oregon Institute of Occupational Health Sciences', 'investigatorFullName': 'Steven A. Shea', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}