Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT02041520
Status:
COMPLETED
Last Update Posted:
2015-08-18
First Post:
2014-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Sponsor:
Organization:
Raw JSON
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Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'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': 'norma.amador@imss.gob.mx', 'phone': '+524777174800', 'title': 'Dr. Norma Amador', 'phoneExt': '31315', 'organization': 'Instituto Mexicano del Seguro Social, UMAE HE No. 1 Bajio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Omega 3 Fatty Acids', 'description': 'omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.\n\nomega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.', 'otherNumAtRisk': 35, 'otherNumAffected': 2, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)\n\nomega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.', 'otherNumAtRisk': 35, 'otherNumAffected': 1, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'dizzines', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'biliar colic in patiet with cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change on Malondialdehyde After 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months follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.18', 'groupId': 'OG000', 'lowerLimit': '-1.94', 'upperLimit': '-0.23'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value', 'unitOfMeasure': 'nM/mg protein', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega 3 Fatty Acids', 'description': 'Patients who received omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and 2 in the night...'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patiemts who received placebo for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '72.2'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '65.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value', 'unitOfMeasure': 'µM', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega 3 Fatty Acids', 'description': 'omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 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administered until progression or unacceptable toxicity develops during 6 months follow up.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '3.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value', 'unitOfMeasure': 'UI/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omega 3 Fatty Acids', 'description': 'omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.\n\nomega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (olive oil gelcaps) 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'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '26.5', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '111.7', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '113.4', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '112.5', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '73.0', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '74.6', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose', 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '91.5', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '90.9', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '184', 'groupId': 'BG000', 'lowerLimit': '162', 'upperLimit': '222'}, {'value': '197', 'groupId': 'BG001', 'lowerLimit': '171', 'upperLimit': '215'}, {'value': '194.5', 'groupId': 'BG002', 'lowerLimit': '165', 'upperLimit': '219'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000', 'lowerLimit': '131', 'upperLimit': '228'}, {'value': '142', 'groupId': 'BG001', 'lowerLimit': '119', 'upperLimit': '206'}, {'value': '173', 'groupId': 'BG002', 'lowerLimit': '126', 'upperLimit': '214'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HDL cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '38', 'upperLimit': '52'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '52'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'LDL cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000', 'lowerLimit': '82', 'upperLimit': '131'}, {'value': '109.7', 'groupId': 'BG001', 'lowerLimit': '99.9', 'upperLimit': '122.5'}, {'value': '107', 'groupId': 'BG002', 'lowerLimit': '88', 'upperLimit': '123'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'VLDL cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '44'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '45'}, {'value': '33', 'groupId': 'BG002', 'lowerLimit': '25.9', 'upperLimit': '44.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Time in HAART', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '82'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '100'}, {'value': '45.5', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Alanine aminotransferase', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '46'}, {'value': '35.5', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '48'}, {'value': '36', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'UI/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Aspartate aminotransferase', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '36'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '37'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'UI/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lipoperoxides', 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'groupId': 'BG000', 'lowerLimit': '1.6', 'upperLimit': '3.1'}, {'value': '2.0', 'groupId': 'BG001', 'lowerLimit': '1.6', 'upperLimit': '2.8'}, {'value': '2.0', 'groupId': 'BG002', 'lowerLimit': '1.6', 'upperLimit': '2.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nM/mg protein', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total-glutathione', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '2.6', 'upperLimit': '30.6'}, {'value': '4.0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '26.4'}, {'value': '5.2', 'groupId': 'BG002', 'lowerLimit': '1.8', 'upperLimit': '28.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μM', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Oxidized-glutathione', 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '11.9'}, {'value': '0.1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2.2'}, {'value': '0.2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μM', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Reduced-glutathione', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '28.8'}, {'value': '2.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '23.1'}, {'value': '3.4', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '26.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μM', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Nitric oxide catabolites', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μM/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4', 'classes': [{'categories': [{'measurements': [{'value': '473', 'groupId': 'BG000', 'lowerLimit': '398', 'upperLimit': '555'}, {'value': '595', 'groupId': 'BG001', 'lowerLimit': '421', 'upperLimit': '765'}, {'value': '488', 'groupId': 'BG002', 'lowerLimit': '407', 'upperLimit': '729'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cel/µL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD8', 'classes': [{'categories': [{'measurements': [{'value': '985', 'groupId': 'BG000', 'lowerLimit': '652', 'upperLimit': '1082'}, {'value': '1117', 'groupId': 'BG001', 'lowerLimit': '742', 'upperLimit': '1553'}, {'value': '1017', 'groupId': 'BG002', 'lowerLimit': '708', 'upperLimit': '1553'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cel/µL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2014-01-17', 'resultsFirstSubmitDate': '2015-02-06', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-06', 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}], 'secondaryOutcomes': [{'measure': 'Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}, {'measure': 'Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}, {'measure': 'Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}, {'measure': 'Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}, {'measure': 'Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}, {'measure': 'Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}, {'measure': 'Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients', 'timeFrame': 'The difference of this value at 6 months in relation to baseline value'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Seropositive HIV', 'Omega 3 fatty acids', 'Oxidative stress'], 'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '27015634', 'type': 'DERIVED', 'citation': 'Amador-Licona N, Diaz-Murillo TA, Gabriel-Ortiz G, Pacheco-Moises FP, Pereyra-Nobara TA, Guizar-Mendoza JM, Barbosa-Sabanero G, Orozco-Avina G, Moreno-Martinez SC, Luna-Montalban R, Vazquez-Valls E. Omega 3 Fatty Acids Supplementation and Oxidative Stress in HIV-Seropositive Patients. A Clinical Trial. PLoS One. 2016 Mar 25;11(3):e0151637. doi: 10.1371/journal.pone.0151637. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in the prevention of complications in seropositive for HIV patients. However, they develop some manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing cardiovascular risk.\n\nClinical trials in general population and in patients on hemodialysis have demonstrated a significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially triglycerides. Also in general populations it has been described a benefit effect of omega 3 acids on oxidative stress.\n\nObjective: to know the effect of omega 3 acids on different markers of oxidative stress in seropositive HIV patients.\n\nMethods: We will perform a randomized parallel controlled clinical trial in seropositive HIV patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid peroxidation products) will be evaluated.\n\nSample size was calculated according to different variables. We selected the biggest one calculated for a difference in nitric oxide of 25% after treatment between groups and a standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of 31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost, a sample size of 35 per group was considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seropositive HIV patients from 20 to 55 years old\n* On clinical score A1, A2, B1 or B2\n* Patients who received highly active antiretroviral therapy for at least 3 months.\n\nExclusion Criteria:\n\n* Patients diagnosed with diabetes mellitus\n* Patients diagnosed with hypertension\n* Patients using hypolipidemic agents or diagnosed with dyslipidemia before receiving HAART therapy.\n* Patients using protease inhibitors'}, 'identificationModule': {'nctId': 'NCT02041520', 'briefTitle': 'Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': 'Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients', 'orgStudyIdInfo': {'id': 'R-2011-785-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega 3 fatty acids', 'description': 'omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.', 'interventionNames': ['Drug: omega 3 fatty acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'omega 3 fatty acids', 'type': 'DRUG', 'otherNames': ['Zonelabs, Marblehead MA'], 'description': 'omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.', 'armGroupLabels': ['Omega 3 fatty acids']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['olive oil'], 'description': 'olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37320', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'Instituto Mexicano del Seguro Social', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}], 'overallOfficials': [{'name': 'Norma Amador, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Mexicano del Seguro Social'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Norma Amador Licona', 'investigatorAffiliation': 'Coordinación de Investigación en Salud, Mexico'}}}}