Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-26 @ 2:26 PM
Study NCT ID:
NCT01054768
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}, {'id': 'D000108', 'term': 'Acetylcarnitine'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ashutosh.lal@ucsf.edu', 'phone': '5104283172', 'title': 'Ashutosh Lal, MD', 'organization': "Children's Hospital & Research Center at Oakland"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Alpha-lipoic Acid and Acetyl-L-carnitine', 'description': 'alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.\n\nalpha-lipoic acid and acetyl-L-carnitine: none to report', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': '1400 mg placebo tablet twice a day for 6 months.\n\nPlacebo: none to report', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Respiratory Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Urgency/UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Vaso-occlusive pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia/Acute Chest Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alpha-lipoic Acid and Acetyl-L-carnitine', 'description': 'alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.\n\nalpha-lipoic acid and acetyl-L-carnitine: none to report'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1400 mg placebo tablet twice a day for 6 months.\n\nPlacebo: none to report'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'C-Reactive Protein (CRP) was measured by a clinical laboratory. Measuring the quantity of serum CRP is helpful in recognizing inflammatory states.', 'unitOfMeasure': 'mg/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reason for discontinuation: started transfusions (2), alternative treatment (2), adverse events (4), subject preference (3).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alpha-lipoic Acid and Acetyl-L-carnitine', 'description': 'alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.\n\nalpha-lipoic acid and acetyl-L-carnitine: none to report'}, {'id': 'FG001', 'title': 'Placebo', 'description': '1400 mg placebo tablet twice a day for 6 months.\n\nPlacebo: none to report'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': "First subject was enrolled 08/10/09. Length of subject involvement was 7 months. Each subject was seen once a month at Children's Hospital \\& Research Center Oakland", 'preAssignmentDetails': 'Exclusions included those with 3 packed red blood transfusions in the past year, illness that could contribute to inflammation, acute sickle cell disease related symptoms requiring a hospital visit, those pregnant or breast feeding, or in other investigational drug or device studies, participants on hydroxyurea or a regular transfusion therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alpha-lipoic Acid and Acetyl-L-carnitine', 'description': 'alpha-lipoic acid and acetyl-L-carnitine 1400 mg tablet twice a day for 6 months.\n\nalpha-lipoic acid and acetyl-L-carnitine: none to report'}, {'id': 'BG001', 'title': 'Placebo', 'description': '1400 mg placebo tablet twice a day for 6 months.\n\nPlacebo: none to report'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2010-01-20', 'resultsFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-13', 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-Reactive Protein', 'timeFrame': '6 months', 'description': 'C-Reactive Protein (CRP) was measured by a clinical laboratory. Measuring the quantity of serum CRP is helpful in recognizing inflammatory states.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antioxidant', 'Inflammation', 'Sickle Cell Disease', 'Oxidative Stress', 'Cytokines', 'anti-inflammatory', 'Acetylcarnitine'], 'conditions': ['Anemia, Sickle Cell']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether alpha-lipoic acid and acetyl-L-carnitine will lower systemic inflammation in patients with Sickle Cell Disease by reducing oxidative stress, which will result in a decrease in the frequency of vaso-occlusive pain episodes and improve their quality of life.', 'detailedDescription': 'People with sickle cell disease have more inflammation (a response of body tissues to injury or irritation) than people without sickle cell disease. This inflammation can be measured in the blood by checking the level of a protein called C reactive protein as well as other changes we see in blood due to inflammation (such as changes in platelets and other cells). There is even more inflammation during sickle-related complications (like pain or acute chest syndrome). We want to test if inflammation in people with sickle cell disease can be reduced by the use of antioxidant compounds.\n\nAntioxidants are nutrients (certain vitamins, minerals and enzymes) that can counteract the effects of oxidative stress arising from free radicals in our cells. The formation of free radicals is a normal cell process, but uncontrolled oxidative stress can cause problems for us. One such harmful problem is inflammation.\n\nWe know from other research studies that antioxidants help with some conditions related to inflammation. In this study the antioxidant being tested is a combination of alpha-lipoic acid and acetyl-L-carnitine, both of which are natural parts of many of the foods we eat and are needed by our cells to make energy from food.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proven diagnosis of sickle cell disease, either homozygous sickle disease or Hb S Beta zero thalassemia genotype\n* Age at entry at least 14 years. Younger children will not be included since the combination alpha-lipoic acid and acetyl-L-carnitine tablets are not available in a smaller dose at this time.\n\nExclusion Criteria:\n\n* More than 3 packed red blood transfusions in the past 12 months\n* Coexisting illness that could contribute to inflammation. These include chronic hepatitis, lupus, arthritis, inflammatory bowel disease, chronic osteomyelitis, and other similar conditions.\n* Acute sickle cell disease related symptoms requiring a hospital visit in the past 4 weeks\n* Women who are pregnant, attempting to get pregnant, or breast feeding\n* Active participation in other investigational drug or device studies\n* Participants who start hydroxyurea or regular transfusion therapy during the course of the study on the recommendation of their primary hematologist will be ineligible for further participation.'}, 'identificationModule': {'nctId': 'NCT01054768', 'briefTitle': 'Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': "UCSF Benioff Children's Hospital Oakland"}, 'officialTitle': 'Antioxidant Therapy to Reduce Inflammation in Sickle Cell Disease', 'orgStudyIdInfo': {'id': '2009-003'}, 'secondaryIdInfos': [{'id': '1R21AT004493-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AT004493-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alpha-lipoic acid and acetyl-L-carnitine', 'description': 'alpha-lipoic acid and acetyl-L-carnitine1400 mg tablet twice a day for 6 months.', 'interventionNames': ['Drug: alpha-lipoic acid and acetyl-L-carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1400 mg placebo tablet twice a day for 6 months.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'alpha-lipoic acid and acetyl-L-carnitine', 'type': 'DRUG', 'otherNames': ['Experimental'], 'description': 'none to report', 'armGroupLabels': ['alpha-lipoic acid and acetyl-L-carnitine']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'none to report', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital & Research Center Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Elliott Vichinsky, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}, {'name': 'Bruce N. Ames, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}, {'name': 'Ashutosh Lal, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}