Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-08 @ 12:14 PM
Study NCT ID:
NCT02497833
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinoic Acid Supplementation and Subjects With Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014212', 'term': 'Tretinoin'}], 'ancestors': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-10', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cholesterol efflux capacity', 'timeFrame': 'changes from baseline in cholesterol efflux capacity at 12 weeks', 'description': 'The cholesterol efflux capacity of the two groups at baseline and after intervention is quantified by a modified method with J774 mouse macrophages. After plated and radiolabeled with 3H-cholesterolper, J774 macrophages are incubation with cAMP and apoB-depleted serum successively. Liquid scintillation counting is used to quantify the efflux of radioactive cholesterol from the cells.'}], 'primaryOutcomes': [{'measure': 'PON1 activity', 'timeFrame': 'changes from baseline in PON1 activity at 12 weeks', 'description': 'PON1 activity is assayed in HDL isolated from plasma of subjects from the placebo and retinoic acid groups by using UV spectrophotometry in a 96-well plate format using phenyl acetate or paraoxon as substrates.'}], 'secondaryOutcomes': [{'measure': 'Lp-PLA2 activity', 'timeFrame': 'changes from baseline in Lp-PLA2 activity at 12 weeks', 'description': 'Lp-PLA2 activity in apoB-depleted plasma after the sedimentation of all apoB-containing lipoproteins with dextran sulfate-magnesium chloride is determined using the trichloroacetic acid precipitation procedure using 2-thio platelet-activation factor as a substrate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity and cholesterol efflux capacity in hypercholesterolemic subjects.', 'detailedDescription': 'Paraoxonase 1 (PON1), an enzyme associated with high-density lipoprotein, is reported to have antioxidant and cardioprotective properties. And all-trans-retinoic acid revealed the ameliorating atherosclerosis effects in many reports.There maybe some correlations between retinoic acid and PON1 activity and the study aim to prove it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* subject has a fasting total cholesterol concentration between 200 and 310mg/dl.\n* subject is between 25 and 65 years of age, inclusive.\n* subjects' BMI is between 18.5 kg/m2 and 35 kg/m2.\n\nExclusion Criteria:\n\n* subject that is pregnant.\n* subject that has coronafy artery desease, diabetes mellitus, thyroid disorders, mental disorder, cancer, cirrhosis, renal disease and hepatic desease.\n* subject that has had operation less than six months prior to screening visit.\n* subject that is smoking.\n* subject uses any drugs that could influence the measurement of lipid paramerters or inflammatiory makers."}, 'identificationModule': {'nctId': 'NCT02497833', 'briefTitle': 'Retinoic Acid Supplementation and Subjects With Hypercholesterolemia', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Effect of Retinoic Acid Supplementation on the HDL-Associated Paraoxonase 1 Activity in Subjects With Hypercholesterolemia: A Randomized, Double-Blinded, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'ZXYZM-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'the participants in this arm are instruted to consume placebo capsules', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'the participants in this arm are instruted to consume retinoic acid capsules', 'interventionNames': ['Dietary Supplement: retinoic acid']}], 'interventions': [{'name': 'retinoic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During the trial period, the participants are instructed to consume retinoic acid capsules twice daily (30 min after breakfast and supper).The retinoic acid capsules provided a total daily intake of 10 mg of retinoic acid.', 'armGroupLabels': ['treatment']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'During the trial period, the participants are instructed to consume placebo capsules twice daily (30 min after breakfast and supper).The placebo capsules are composed of starch and pigment.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Min Xia, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Medicine', 'investigatorFullName': 'Di Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}