Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-09 @ 7:58 PM
Study NCT ID:
NCT00551434
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2007-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Creatine and L-Arginine on Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-30', 'studyFirstSubmitDate': '2007-10-30', 'studyFirstSubmitQcDate': '2007-10-30', 'lastUpdatePostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brachial artery flow-mediated dilation', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'serum arginine, creatine, creatinine, homocysteine', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The study is a double blind 2x2 factorial study. Patients with coronary disease will be randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary supplement. The function of the endothelium will be tested using ultrasound before and after each treatment. These studies will help us understand why the endothelium is abnormal in patients with coronary artery disease and how L-arginine is acting on endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery disease\n\nExclusion Criteria:\n\n* Pregnancy\n* Creatine use within one month of study\n* L-arginine use within one month of study\n* Change in dose or initiation of lipid lowering therapy, aspirin therapy, or angiotensin converting enzyme therapy within one month of study'}, 'identificationModule': {'nctId': 'NCT00551434', 'briefTitle': 'Effect of Creatine and L-Arginine on Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Effect of Creatine and L-Arginine on Endothelial Function in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'H-22852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: Creatine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Dietary Supplement: l-arginine']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Dietary Supplement: L-arginine and creatine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Dietary Supplement: placebo, double']}], 'interventions': [{'name': 'Creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine 21 g daily', 'armGroupLabels': ['1']}, {'name': 'L-arginine and creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'L-arginine', 'armGroupLabels': ['3']}, {'name': 'l-arginine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'l-arginine 9 g daily', 'armGroupLabels': ['2']}, {'name': 'placebo, double', 'type': 'DIETARY_SUPPLEMENT', 'description': 'placebo', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joseph A Vita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}}}}