Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT03411369
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D012266', 'term': 'Ribose'}, {'id': 'D013831', 'term': 'Thiamine'}, {'id': 'D025101', 'term': 'Vitamin B 6'}], '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': 'D010429', 'term': 'Pentoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind study design. The dietary supplement of Creatine, D-Ribose, B1 Vitamin, and B6 vitamin will come in the form of water-soluble powder in sachets of 4 grams. Each sachet contains 1 gram of Creatine, 2.5 grams of D-Ribose, 0.33 mg of B1 vitamin and 0.42 mg of B6 vitamin. The same administration will come for placebo group with the inert product sachets consisting of starch powder.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'mg/dl'}, {'measure': 'Total cholesterol', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'mg/dl'}, {'measure': 'LDL-cholesterol', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'mg/dl'}, {'measure': 'HDL-cholesterol', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'mg/dl'}, {'measure': 'Triglycerides', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'mg/dl'}, {'measure': 'Creatinine', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'mg/dl'}, {'measure': 'Alanine transaminase', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'UI/l'}, {'measure': 'Water composition', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'Percentage'}, {'measure': 'Fat mass', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'Percentage'}, {'measure': 'Free fat mass', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'Percentage'}, {'measure': 'Chronotropic index', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'bpm'}, {'measure': 'Cardiac double product at the peak of the load', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'It will be calculated by multiplying systolic blood pressure and heart rate'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'Kg/m2'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'mmHg'}, {'measure': 'Heart Rate', 'timeFrame': 'Change from Baseline at 6 months', 'description': 'bpm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Creatine, ribose, ischemic heart disease.'], 'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': "Recently, researchers have paid attention to the development of new products such as supplements food and nutraceuticals for identify and develop integrative therapies to be used in cardiovascular disease. As suggested by literature, some nutritional components (creatine, ribose) can enhance the fundamental energy levels for the functioning of the heart muscle and can enhance the body's antioxidant capacity through the reduction in free radicals activity, one of the main pathogenic mechanisms of these diseases. In this context, the investigators have developed a research with the principal purpose to establish whether a supplement of creatine and ribose can improve the total work capacity during exercise in a population of patients with known ischemic heart disease.", 'detailedDescription': 'The investigators will enroll patients with previous acute coronary syndrome treated for at least 30 days by hospital discharge. The treatment regimen of all patients will be optimized in accordance with European Society of Cardiology guidelines. Standardized pharmacological treatment during cardiac rehabilitation period will include administration of angiotensin converting enzyme inhibition (ACE), beta-blockers and antiplatelet blockers. Furthermore, in order to keep patients free from angina symptoms, in some cases calcium channel blockers and/or nitrates will be used. The investigators will randomize participants into two groups, one receiving treatment Creatine, D-Ribose, B1 Vitamin, and B6 vitamin, and one receiving placebo in a double blind study design, for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge\n\nExclusion Criteria:\n\n* oncological diseases\n* stable atrial fibrillation\n* stent in the common core\n* patients who are not able to perform physical activities\n* patients with documented sustained ventricular arrhythmias\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT03411369', 'briefTitle': 'Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled Study To Evaluate The Effectiveness Of A Food Supplement Containing Creatine And D-Ribose In Increasing Stress Tolerance In Patients With Ischemic Heart Disease', 'orgStudyIdInfo': {'id': '23473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine, D-Ribose, B1 Vitamin, and B6 vitamin', 'description': 'Water-soluble powder in sachets of 4 grams. Each sachet contains 1 gram of Creatine, 2.5 grams of D-Ribose, 0.33 mg of B1 vitamin and 0.42 mg of B6 vitamin.', 'interventionNames': ['Dietary Supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Creatine, D-Ribose, B1 Vitamin, and B6 vitamin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Crebox'], 'description': 'The treatment will consist of taking 2 sachets / day for the first two weeks, and then continuing with 1 sachet/day for the next month.', 'armGroupLabels': ['Creatine, D-Ribose, B1 Vitamin, and B6 vitamin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'University of Pavia'}}}}