Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00915902
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2009-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fish Oil Study for High Triglyceride Levels in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], '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': 'C405603', 'term': 'Omacor'}, {'id': 'D003314', 'term': 'Corn Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cprosper@nemours.org', 'phone': '302-651-6686', 'title': 'Research Coordinator', 'organization': 'Nemours Alfred I. duPont Hospital for Children'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Intrinsic variability of triglycerides is large and may have confounded analyses; 4-week washout between treatment periods may have been too short; a reduction of triglycerides in the corn oil placebo group may have compromised the results.'}}, 'adverseEventsModule': {'timeFrame': 'During the 20 week duration of the clinical trial. Specifically, during the first 8 week treatment period, the subsequent 4 week washout period, and the following 8 week treatment period.', 'description': 'Adverse Events were only collected and reported during the clinical trial, not after the conclusion of the trial, or prior to its start.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Lovaza) Followed by Placebo, During Treatment', 'description': 'Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment (Lovaza) Followed by Placebo, During Placebo', 'description': 'Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Followed by Treatment (Lovaza), During Placebo', 'description': 'Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Followed by Treatment (Lovaza), During Treatment', 'description': 'Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'depression, worsening', 'notes': 'hospital stay for depression, worsening. not related to study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Triglyceride Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3-acid Ethyl Esters (Lovaza)', 'description': 'Omega-3-acid ethyl esters: Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo, two 1-gram capsules taken twice daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-52', 'spread': '16', 'groupId': 'OG000'}, {'value': '-16', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 8 week treatment or placebo period', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lovaza Then Placebo', 'description': 'Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks'}, {'id': 'FG001', 'title': 'Placebo Then Lovaza', 'description': 'Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks'}], 'periods': [{'title': '1st Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '2nd Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited from Nemours Alfred I. duPont Hospital for Children, Johns Hopkins University and Thomas Jefferson University. Recruitment took place between July 2009 and December 2011.', 'preAssignmentDetails': 'Patients completed a 4 week dietary run-in prior to randomization at visit 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Lovaza) Followed by Placebo', 'description': 'Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks'}, {'id': 'BG001', 'title': 'Placebo Followed by Treatment (Lovaza)', 'description': 'Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '14.2', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '14.1', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Triglyceride (mg/dL', 'classes': [{'categories': [{'measurements': [{'value': '260', 'spread': '22', 'groupId': 'BG000'}, {'value': '280', 'spread': '25', 'groupId': 'BG001'}, {'value': '270', 'spread': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2009-06-04', 'resultsFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Triglyceride Level', 'timeFrame': 'after 8 week treatment or placebo period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'High triglyceride levels are increasingly recognized in children, particularly those who are overweight. There are no studies of treatment of high triglycerides in children and adolescents. Fish oil is attractive because it is considered safe and effective for treating high triglycerides in adults and has been used safely for other purposes in children. The investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides, safety, and possible mechanisms of beneficial effects.', 'detailedDescription': 'Participants (n = 42, age 14 + 2 yrs) with hypertriglyceridemia and LDL cholesterol \\< 160 mg/dl were enrolled in a randomized double blind cross over trial comparing 4 g fish oil daily with placebo. Treatment interval was 8 weeks with a 4 week wash out, between the two treatment intervals. Lipid profile, lipoprotein particle distribution and size, glucose, insulin, high sensitivity C reactive protien (CRP), interleukin-6, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), and thrombin generation were measured.\n\nPatients were evaluated at 6 time points: Visit 1/baseline (week 0), Visit 2/randomization (week 4), Visit 3/after treatment 1 (week 12) , Visit 4/after wash out (week 16), Visit 5/after treatment 2 (week 24) and Visit 6/close out (week 28) . Patients were advised to maintain a stable diet and not alter baseline fish consumption . One participant took an oral contraceptive throughout the trial. Any fish oil supplements were discontinued. Advice on a heart healthy diet was provided. Blood pressure (right arm sitting with appropriate sized cuff, taken 3 times, last measurement used), height, and weight were measured at the beginning of the study, after the first wash out period, and close out. Participant phone contact was made during each treatment arm to assess diet stability. Fasting lipid profile was performed at every visit. Red blood cell fatty acid profile and secondary endpoints were performed at all visits except baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients who are 10-17 years of age\n* Fasting triglyceride level \\>150 mg/dl and \\< 750 mg/dl measured on 2 separate occasions.\n* Ability to follow the study procedures and adhere to the diet counseling recommendations\n* Written parental permission and assent are obtained prior to any research procedures\n\nExclusion Criteria:\n\n* Bleeding disorders\n* Diabetes mellitus (impaired glucose tolerance is not an exclusion)\n* Uncontrolled hypothyroidism\n* Liver disease\n* Allergy to fish/shellfish\n* Patients requiring chronic use of aspirin and non-steroidal anti-inflammatory agents\n* Patients requiring lipid lowering agents\n* LDL-Cholesterol levels \\>160 mg/dl\n* Current participation in another clinical study or within the previous 30 days\n* Alcohol use\n* Currently pregnant or planning to become pregnant during the course of this trial (confirmed by pregnancy testing)\n* Any significant medical condition which the investigator believes would interfere with the patient's ability to safely participate in this trial"}, 'identificationModule': {'nctId': 'NCT00915902', 'briefTitle': 'Fish Oil Study for High Triglyceride Levels in Children', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents', 'orgStudyIdInfo': {'id': 'GIDDING'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3-acid ethyl esters (Lovaza)', 'description': 'This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. GlaxoSmithKline supplied the study drug and the placebo. The study drug, Omega-3-acid ethyl esters (Lovaza) was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week treatment period. The study drug contained minimally 1.5 g DHA (docosahexaenoic acid) and 1.86 g EPA (eicosapentaenoic acid).', 'interventionNames': ['Drug: Omega-3-acid ethyl esters']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. The corn oil placebo was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week non-treatment (placebo) period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Omega-3-acid ethyl esters', 'type': 'DRUG', 'otherNames': ['Lovaza'], 'description': 'Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks', 'armGroupLabels': ['Omega-3-acid ethyl esters (Lovaza)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Corn Oil'], 'description': 'Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'A. I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferon University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Samuel Gidding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nemours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Babu Balagopal', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Thomas Jefferson University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Research Scientist', 'investigatorFullName': 'Babu Balagopal', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}