Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT01351805
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2011-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D015118', 'term': 'Eicosapentaenoic Acid'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kcostenbader@bwh.harvard.edu', 'phone': '16177326088', 'title': 'Karen Costenbader', 'organization': "Brigham and Women's Hospital/ Harvard Medical School"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': "Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleeding, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash\n\nOmega-3 FA Monitored safety cond'ns: GI bleeding; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping", 'eventGroups': [{'id': 'EG000', 'title': 'Active Vitamin D/ Active Omega-3 Fatty Acids', 'description': 'Vitamin D3, one 2000 IU capsule/day\n\nOmacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).', 'otherNumAtRisk': 6463, 'deathsNumAtRisk': 6463, 'otherNumAffected': 5101, 'seriousNumAtRisk': 6463, 'deathsNumAffected': 241, 'seriousNumAffected': 791}, {'id': 'EG001', 'title': 'Active Vitamin D/ Active Omega-3 Placebo', 'description': 'Vitamin D3, one 2000 IU capsule/day\n\nOmega-3 fatty acids placebo, one capsule/day', 'otherNumAtRisk': 6464, 'deathsNumAtRisk': 6464, 'otherNumAffected': 5027, 'seriousNumAtRisk': 6464, 'deathsNumAffected': 244, 'seriousNumAffected': 782}, {'id': 'EG002', 'title': 'Active Omega-3 Fatty Acids, Placebo Vitamin D', 'description': 'Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).\n\nVitamin D placebo, one capsule/day', 'otherNumAtRisk': 6470, 'deathsNumAtRisk': 6470, 'otherNumAffected': 5037, 'seriousNumAtRisk': 6470, 'deathsNumAffected': 252, 'seriousNumAffected': 822}, {'id': 'EG003', 'title': 'Omega-3 Fatty Acids Placebo/ Placebo Vitamin D', 'description': 'Omega-3 fatty acids placebo, one capsule/day\n\nVitamin D placebo, one capsule/day', 'otherNumAtRisk': 6474, 'deathsNumAtRisk': 6474, 'otherNumAffected': 5101, 'seriousNumAtRisk': 6474, 'deathsNumAffected': 241, 'seriousNumAffected': 837}], 'otherEvents': [{'term': 'Easy bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 1737}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 1697}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 1706}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 1702}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Frequent nosebleeds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 224}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 242}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 241}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 249}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 469}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 442}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 450}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 432}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parathyroid condition', 'notes': 'Parathyroid condition = hyperparathyroidism or hypoparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 34}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach upset or pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 2439}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 2421}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 2448}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 2422}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 1748}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 1771}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 1810}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 1779}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 2567}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 2566}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 2617}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 2545}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 2781}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 2730}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 2818}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 2850}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased burping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 1107}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 1061}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 1110}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 1097}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bad taste in mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 1109}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 1086}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 1131}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 1159}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 233}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 244}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 197}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 229}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney failure or dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 45}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 1629}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 1639}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 1702}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 1728}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 171}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 200}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 203}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 74}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 69}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Invasive cancer of any type', 'notes': 'Total cancer = invasive cancer of any type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 408}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 385}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 412}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 412}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death from cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 93}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 94}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer (in women)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 65}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer (in men)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 110}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 109}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 21}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major cardiovascular event', 'notes': 'Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 210}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 200}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 209}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 73}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 103}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 67}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death from cardiovascular causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6463, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 6464, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 6470, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 6474, 'numAffected': 70}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '784', 'groupId': 'OG000'}, {'value': '777', 'groupId': 'OG001'}, {'value': '784', 'groupId': 'OG002'}, {'value': '777', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Vitamin D', 'description': 'Vitamin D3, one 2000 IU capsule/day'}, {'id': 'OG001', 'title': 'Placebo Vitamin D', 'description': 'Vitamin D placebo, one capsule/day'}, {'id': 'OG002', 'title': 'Active n-3 FA', 'description': 'Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).'}, {'id': 'OG003', 'title': 'Placebo n-3 FA', 'description': 'Omega-3 fatty acids placebo, one capsule/day'}], 'classes': [{'title': 'Baseline ln (IL-6) pg/ml, geometric mean (95% Cl)', 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '1.65', 'upperLimit': '1.78'}, {'value': '1.68', 'groupId': 'OG001', 'lowerLimit': '1.61', 'upperLimit': '1.74'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.63', 'upperLimit': '1.75'}, {'value': '1.70', 'groupId': 'OG003', 'lowerLimit': '1.63', 'upperLimit': '1.77'}]}]}, {'title': 'Year 1 ln (IL-6) pg/mL, geometric mean (95% CI)', 'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '1.87'}, {'value': '1.63', 'groupId': 'OG001', 'lowerLimit': '1.57', 'upperLimit': '1.69'}, {'value': '1.70', 'groupId': 'OG002', 'lowerLimit': '1.64', 'upperLimit': '1.77'}, {'value': '1.72', 'groupId': 'OG003', 'lowerLimit': '1.66', 'upperLimit': '1.79'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent change in geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.19', 'ciLowerLimit': '1.52', 'ciUpperLimit': '15.31', 'pValueComment': 'IL-6 from baseline to one year: overall % change= 8.19% (95%CI 1.52-15.31).', 'groupDescription': 'Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.', 'statisticalMethod': 'as above', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.', 'nonInferiorityComment': 'Test of change from baseline as above.'}, {'pValue': '0.97', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percent change in geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-6.87', 'ciUpperLimit': '5.81', 'pValueComment': '4\\. IL-6 from baseline to one year: overall % change= -0.73% (95%CI -6.87 to 5.81).', 'groupDescription': 'Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.', 'statisticalMethod': 'as above', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p above adjusted for age, sex, race and vitamin D randomized treatment group.', 'nonInferiorityComment': 'Test of change from baseline as above.'}, {'pValue': '0.12', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'Test of multiplicative interaction between the effects of the two supplements', 'groupDescription': 'Test for interaction between effect of vitamin D and effect of omega-3 fatty acids on IL-6 change from baseline to 1 year', 'statisticalMethod': 'p for interaction', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1,p for interaction between strata.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 1 year', 'description': 'In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the IL-6 serum biomarker of systemic inflammation.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subsample of the VITAL trial participants at baseline and one year.'}, {'type': 'PRIMARY', 'title': 'Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '784', 'groupId': 'OG000'}, {'value': '777', 'groupId': 'OG001'}, {'value': '784', 'groupId': 'OG002'}, {'value': '777', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Vitamin D', 'description': 'Vitamin D3, one 2000 IU capsule/day'}, {'id': 'OG001', 'title': 'Placebo Vitamin D', 'description': 'Vitamin D placebo, one capsule/day'}, {'id': 'OG002', 'title': 'Active n-3 FA', 'description': 'Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).'}, {'id': 'OG003', 'title': 'Placebo n-3 FA', 'description': 'Omega-3 fatty acids placebo, one capsule/day'}], 'classes': [{'title': 'Baseline ln (hsCRP) mg/L, geometric mean (95% Cl)', 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '1.57'}, {'value': '1.51', 'groupId': 'OG001', 'lowerLimit': '1.43', 'upperLimit': '1.60'}, {'value': '1.57', 'groupId': 'OG002', 'lowerLimit': '1.49', 'upperLimit': '1.66'}, {'value': '1.43', 'groupId': 'OG003', 'lowerLimit': '1.35', 'upperLimit': '1.51'}]}]}, {'title': 'Year 1 ln (hsCRP) mg/L, geometric mean (95% CI)', 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '1.71'}, {'value': '1.54', 'groupId': 'OG001', 'lowerLimit': '1.46', 'upperLimit': '1.63'}, {'value': '1.63', 'groupId': 'OG002', 'lowerLimit': '1.54', 'upperLimit': '1.72'}, {'value': '1.53', 'groupId': 'OG003', 'lowerLimit': '1.45', 'upperLimit': '1.62'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent change in geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.12', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '16.87', 'pValueComment': '3\\. HsCRP from baseline to one year: overall % change= 7.12% (95%CI -1.81-16.78).', 'groupDescription': 'Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.', 'statisticalMethod': 'as above', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.', 'nonInferiorityComment': 'Test of change from baseline as above.'}, {'pValue': '0.44', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percent change in geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.89', 'ciLowerLimit': '-11.92', 'ciUpperLimit': '4.86', 'pValueComment': '6\\. HsCRP from baseline to one year: overall % change= -3.89% (95%CI -11.92-4.86).', 'groupDescription': 'Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.', 'statisticalMethod': 'as above', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p above adjusted for age, sex, race and vitamin D randomized treatment group.', 'nonInferiorityComment': 'Test of change from baseline as above.'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.', 'statisticalMethod': 'P for interaction', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 1 year', 'description': 'In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the CRP serum biomarker of systemic inflammation.', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subsample of the VITAL trial participants at baseline and one year.'}, {'type': 'PRIMARY', 'title': 'Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '784', 'groupId': 'OG000'}, {'value': '777', 'groupId': 'OG001'}, {'value': '784', 'groupId': 'OG002'}, {'value': '777', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Vitamin D', 'description': 'Vitamin D3, one 2000 IU capsule/day'}, {'id': 'OG001', 'title': 'Placebo Vitamin D', 'description': 'Vitamin D placebo, one capsule/day'}, {'id': 'OG002', 'title': 'Active n-3 FA', 'description': 'Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).'}, {'id': 'OG003', 'title': 'Placebo n-3 FA', 'description': 'Omega-3 fatty acids placebo, one capsule/day'}], 'classes': [{'title': 'Baseline ln (TNFR2) pg/ml, geometric mean (95% Cl)', 'categories': [{'measurements': [{'value': '2546.5', 'groupId': 'OG000', 'lowerLimit': '2508.6', 'upperLimit': '2584.9'}, {'value': '2525.4', 'groupId': 'OG001', 'lowerLimit': '2482.7', 'upperLimit': '2568.9'}, {'value': '2571.3', 'groupId': 'OG002', 'lowerLimit': '2528.1', 'upperLimit': '2615.2'}, {'value': '2500.9', 'groupId': 'OG003', 'lowerLimit': '2463.6', 'upperLimit': '2538.8'}]}]}, {'title': 'Year 1 ln (TNFR2) pg/mL, geometric mean (95% CI)', 'categories': [{'measurements': [{'value': '2604.7', 'groupId': 'OG000', 'lowerLimit': '2565.2', 'upperLimit': '2644.7'}, {'value': '2567.9', 'groupId': 'OG001', 'lowerLimit': '2523.9', 'upperLimit': '2612.7'}, {'value': '2605.3', 'groupId': 'OG002', 'lowerLimit': '2561.4', 'upperLimit': '2649.9'}, {'value': '2567.3', 'groupId': 'OG003', 'lowerLimit': '2527.7', 'upperLimit': '2607.6'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent change in geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '2.31', 'pValueComment': '2\\. TNFR2 from baseline to one year: overall % change= 0.63% (95%CI -1.03 to 2.31).', 'groupDescription': 'Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.', 'statisticalMethod': 'as above', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.', 'nonInferiorityComment': 'Test of change from baseline as above.'}, {'pValue': '0.13', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percent change in geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-2.89', 'ciUpperLimit': '0.39', 'pValueComment': '5\\. TNFR2 from baseline to one year: overall % change= -1.27% (95%CI -2.89 to 0.39).', 'groupDescription': 'Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.', 'statisticalMethod': 'as above', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p above adjusted for age, sex, race and vitamin D randomized treatment group.', 'nonInferiorityComment': 'Test of change from baseline as above.'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.', 'statisticalMethod': 'P for interaction', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1 with p for interaction between strata.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 1 year', 'description': 'In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the TNFR2 serum biomarker of systemic inflammation.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subsample of the VITAL trial participants at baseline and one year.'}, {'type': 'PRIMARY', 'title': 'Incident Autoimmune Diseases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12927', 'groupId': 'OG000'}, {'value': '12944', 'groupId': 'OG001'}, {'value': '12933', 'groupId': 'OG002'}, {'value': '12938', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Vitamin D', 'description': 'Vitamin D3, one 2000 IU capsule/day'}, {'id': 'OG001', 'title': 'Placebo Vitamin D', 'description': 'Vitamin D placebo, one capsule/day'}, {'id': 'OG002', 'title': 'Active n-3 FA', 'description': 'Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).'}, {'id': 'OG003', 'title': 'Placebo n-3 FA', 'description': 'Omega-3 fatty acids placebo, one capsule/day'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '148', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.99', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.19', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.20', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Test for multiplicative interaction between the effects of randomized treatment groups, vitamin D and n-3 fa on incidence of autoimmune disease.', 'statisticalMethod': 'P for interaction', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p multiplicative interaction between effects of vitamin D and n-3 fa supplements'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'All participants were followed for the development of new autoimmune diseases, including, but not limited to, rheumatoid arthritis, psoriasis, autoimmune thyroid disease, inflammatory bowel disease and polymyalgia rheumatica. The primary endpoint was all incident autoimmune disease confirmed by extensive medical record review. Participants self-reported all incident autoimmune diseases from baseline through follow-up. We used Cox proportional hazards models to test the effects of vitamin D and n-3 fatty acids upon autoimmune disease incidence.\n\nWe compared the separate main effects of vitamin D or n-3 fatty acid supplement assignment on AD incidence using Cox regression models. To account for randomization stratification and study design, we additionally adjusted for age, sex, self-reported race, and randomization to the other supplement. Person-time was counted until diagnosis of a new confirmed AD, death, or the end of the trial. We also test interactions between the two supplements', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in VITAL followed for the development of new autoimmune diseases, including, but not limited to, rheumatoid arthritis, psoriasis, autoimmune thyroid disease, inflammatory bowel disease and polymyalgia rheumatica. Categorized by vitamin D (active/placebo) and n-3 (active/placebo)'}, {'type': 'PRIMARY', 'title': 'Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA & Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '595', 'groupId': 'OG000'}, {'value': '626', 'groupId': 'OG001'}, {'value': '591', 'groupId': 'OG002'}, {'value': '630', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active n-3 FA', 'description': 'Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA) + Vitamin D3, one 2000 IU capsule/day or Vitamin D placebo, one capsule/day'}, {'id': 'OG001', 'title': 'Placebo n-3 FA', 'description': 'Omega-3 fatty acids placebo, one capsule/day + Vitamin D3, one 2000 IU capsule/day or Vitamin D placebo, one capsule/day'}, {'id': 'OG002', 'title': 'Active Vitamin D', 'description': 'Vitamin D3, one 2000 IU capsule/day + Omega 3 Omacor fatty acid, 1-g capsule/day or Omega-3 fatty acid placebo'}, {'id': 'OG003', 'title': 'Placebo Vitamin D', 'description': 'Placebo vitamin D3, one 2000 IU capsule/day + Omega 3 Omacor fatty acid, 1-g capsule/day or Omega-3 fatty acid placebo'}], 'classes': [{'title': 'Baseline mean WOMAC Pain', 'categories': [{'measurements': [{'value': '36.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '35.4', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '36.5', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Follow Up mean WOMAC pain', 'categories': [{'measurements': [{'value': '33.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '32.7', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '34.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.', 'groupDescription': 'Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Repeated measures model with censoring for total knee replacement.', 'nonInferiorityComment': 'We assessed the main effects of the treatment arms comparing all those randomized to omega-3 fatty acids or omega-3 fatty acid placebo, regardless of vitamin D randomization status.'}, {'pValue': '0.41', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.', 'groupDescription': 'Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear time by treatment interaction (comparing change in WOMAC pain over time in two randomized groups)', 'nonInferiorityComment': 'We assessed the main effects of the treatment arms comparing all those randomized to vitamin D or vitamin D placebo, regardless of omega-3 fatty acid randomization status.', 'otherAnalysisDescription': 'We assessed for effect modification between vitamin D and N-3 FA and tested for other pre-specified interactions. We again used a repeated measures model with censoring for TKR. We adjusted for age, sex and N-3 FA treatment arm (in analyses in which N-3 FA treatment arm was not investigated as a potential modifier).'}, {'pValue': '0.42', 'groupIds': ['OG000', 'OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'groupDescription': 'Active n3fa vs placebo n3fa among those on placebo vitamin D.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.'}, {'pValue': '0.18', 'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8', 'groupDescription': 'Vitamin D vs. vitamin D placebo among those on placebo omega-3 fatty acids- stratified analyses.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.'}, {'pValue': '0.84', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.89', 'groupDescription': 'Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on active vitamin D.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.'}, {'pValue': '0.76', 'groupIds': ['OG000', 'OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.80', 'groupDescription': 'Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on placebo vitamin D.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 5 years', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain was the primary outcome on a scale of 0-100 with 100= worst pain.\n\nSubsample of VITAL participants with chronic, frequent knee pain at trial baseline were followed with annual WOMAC questionnaires to test for change in severity of chronic knee pain in those taking Omega-3 fish oil (n-3 FA) supplements compared to those taking placebo and for those taking Vitamin D supplements compared to those taking placebo. We tested whether n-3 FA supplements and Vitamin D are associated with reduced levels of WOMAC knee pain at the end of the trial (comparing knee pain outcomes in those receiving supplements to placebo). We will also test whether there were multiplicative interactions between the two supplements for the outcome of knee pain severity by WOMAC-Pain index', 'unitOfMeasure': 'WOMAC units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subsample of the VITAL trial who reported chronic frequent knee pain prior to randomization.'}, {'type': 'SECONDARY', 'title': 'Incident Autoimmune Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12927', 'groupId': 'OG000'}, {'value': '12944', 'groupId': 'OG001'}, {'value': '12933', 'groupId': 'OG002'}, {'value': '12938', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Vitamin D', 'description': '2000IU vitamin D3 orally per day'}, {'id': 'OG001', 'title': 'Placebo Vitamin D', 'description': 'placebo pill: placebo'}, {'id': 'OG002', 'title': 'Active n-3 FA', 'description': 'marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]) orally per day'}, {'id': 'OG003', 'title': 'Placebo n-3 FA', 'description': 'placebo pill: placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}, {'value': '280', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'pValueComment': 'HR with 95%CI', 'groupDescription': 'HR for incident autoimmune disease in intervention groups vs. placebo (ref=1.0) using Cox models with 95% confidence intervals', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'extension of follow-up through 2 years post trial closure, up to 7 years', 'description': 'Development of new autoimmune disease through observational follow-up after trial termination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline enrolled populations'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids', 'description': 'ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]).'}, {'id': 'FG001', 'title': 'ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids', 'description': 'ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day'}, {'id': 'FG002', 'title': 'PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids', 'description': 'PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]).'}, {'id': 'FG003', 'title': 'PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids', 'description': 'PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6463'}, {'groupId': 'FG001', 'numSubjects': '6464'}, {'groupId': 'FG002', 'numSubjects': '6470'}, {'groupId': 'FG003', 'numSubjects': '6474'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6463'}, {'groupId': 'FG001', 'numSubjects': '6464'}, {'groupId': 'FG002', 'numSubjects': '6470'}, {'groupId': 'FG003', 'numSubjects': '6474'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From the 25871 VITAL participants, we identified 2 main subcohorts: A "systemic inflammation" subcohort of 1561 participants with sufficient blood biomarker assays, balanced by sex, and matched on blood draw season, and a second "knee pain" subcohort including 1,398 participants who returned one knee pain questionnaire and qualified at baseline. Both subcohorts are described below in their respective aims.', 'preAssignmentDetails': 'At 1 year, 95% of participants returned follow-up questionnaires, and approximately 90% were taking more than two-thirds of study pills (definition of compliance).\n\nParticipants willing to provide a blood sample were sent a kit with consent form, supplies, and instructions to have blood drawn.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6463', 'groupId': 'BG000'}, {'value': '6464', 'groupId': 'BG001'}, {'value': '6470', 'groupId': 'BG002'}, {'value': '6474', 'groupId': 'BG003'}, {'value': '25871', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids', 'description': 'ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]).'}, {'id': 'BG001', 'title': 'ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids', 'description': 'ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day'}, {'id': 'BG002', 'title': 'PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids', 'description': 'PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]).'}, {'id': 'BG003', 'title': 'PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids', 'description': 'PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2458', 'groupId': 'BG000'}, {'value': '2462', 'groupId': 'BG001'}, {'value': '2461', 'groupId': 'BG002'}, {'value': '2467', 'groupId': 'BG003'}, {'value': '9848', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '4005', 'groupId': 'BG000'}, {'value': '4002', 'groupId': 'BG001'}, {'value': '4009', 'groupId': 'BG002'}, {'value': '4007', 'groupId': 'BG003'}, {'value': '16023', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '67.2', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '67.1', 'spread': '7.1', 'groupId': 'BG003'}, {'value': '67.1', 'spread': '7.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '3276', 'groupId': 'BG000'}, {'value': '3271', 'groupId': 'BG001'}, {'value': '3271', 'groupId': 'BG002'}, {'value': '3267', 'groupId': 'BG003'}, {'value': '13085', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '3187', 'groupId': 'BG000'}, {'value': '3193', 'groupId': 'BG001'}, {'value': '3199', 'groupId': 'BG002'}, {'value': '3207', 'groupId': 'BG003'}, {'value': '12786', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic white', 'categories': [{'measurements': [{'value': '4515', 'groupId': 'BG000'}, {'value': '4498', 'groupId': 'BG001'}, {'value': '4529', 'groupId': 'BG002'}, {'value': '4504', 'groupId': 'BG003'}, {'value': '18046', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1278', 'groupId': 'BG000'}, {'value': '1275', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}, {'value': '1282', 'groupId': 'BG003'}, {'value': '5106', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic (not African American)', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}, {'value': '1013', 'groupId': 'BG004'}]}]}, {'title': 'Asian/Pacific Islander', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}]}]}, {'title': 'Native American/ Alaskan Native', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '228', 'groupId': 'BG004'}]}]}, {'title': 'Other/ unknown', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '523', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race/Ethnicity measured using different categories in systemic inflammation versus knee pain subcohorts.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6463', 'groupId': 'BG000'}, {'value': '6464', 'groupId': 'BG001'}, {'value': '6470', 'groupId': 'BG002'}, {'value': '6474', 'groupId': 'BG003'}, {'value': '25871', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'In this 2x2 factorial design trial, the primary analyses were: all active vitamin D vs. all placebo vitamin D and all active omega-3 fatty acids vs. all placebo omega-3 fatty acids.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-11-09', 'size': 541551, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-10T11:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25871}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2011-05-04', 'resultsFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2020-12-10', 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)', 'timeFrame': 'Baseline and 1 year', 'description': 'In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the IL-6 serum biomarker of systemic inflammation.'}, {'measure': 'Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)', 'timeFrame': 'Baseline and 1 year', 'description': 'In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the CRP serum biomarker of systemic inflammation.'}, {'measure': 'Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2)', 'timeFrame': 'Baseline and 1 year', 'description': 'In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the TNFR2 serum biomarker of systemic inflammation.'}, {'measure': 'Incident Autoimmune Diseases', 'timeFrame': '5 years', 'description': 'All participants were followed for the development of new autoimmune diseases, including, but not limited to, rheumatoid arthritis, psoriasis, autoimmune thyroid disease, inflammatory bowel disease and polymyalgia rheumatica. The primary endpoint was all incident autoimmune disease confirmed by extensive medical record review. Participants self-reported all incident autoimmune diseases from baseline through follow-up. We used Cox proportional hazards models to test the effects of vitamin D and n-3 fatty acids upon autoimmune disease incidence.\n\nWe compared the separate main effects of vitamin D or n-3 fatty acid supplement assignment on AD incidence using Cox regression models. To account for randomization stratification and study design, we additionally adjusted for age, sex, self-reported race, and randomization to the other supplement. Person-time was counted until diagnosis of a new confirmed AD, death, or the end of the trial. We also test interactions between the two supplements'}, {'measure': 'Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA & Vitamin D', 'timeFrame': 'Baseline and 5 years', 'description': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain was the primary outcome on a scale of 0-100 with 100= worst pain.\n\nSubsample of VITAL participants with chronic, frequent knee pain at trial baseline were followed with annual WOMAC questionnaires to test for change in severity of chronic knee pain in those taking Omega-3 fish oil (n-3 FA) supplements compared to those taking placebo and for those taking Vitamin D supplements compared to those taking placebo. We tested whether n-3 FA supplements and Vitamin D are associated with reduced levels of WOMAC knee pain at the end of the trial (comparing knee pain outcomes in those receiving supplements to placebo). We will also test whether there were multiplicative interactions between the two supplements for the outcome of knee pain severity by WOMAC-Pain index'}], 'secondaryOutcomes': [{'measure': 'Incident Autoimmune Disease', 'timeFrame': 'extension of follow-up through 2 years post trial closure, up to 7 years', 'description': 'Development of new autoimmune disease through observational follow-up after trial termination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vitamin D', 'omega-3 fatty acid', 'fish oil', 'prevention', 'trial', 'autoimmune disease', 'rheumatoid arthritis', 'psoriasis', 'systemic inflammation', 'Interleukin-6', 'C-reactive peptide', 'tumor necrosis factor', 'osteoarthritis'], 'conditions': ['Autoimmune Diseases', 'Systemic Inflammatory Process', 'Knee Pain Chronic', 'Osteoarthritis', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '38518540', 'type': 'RESULT', 'citation': 'Oakes EG, Vlasakov I, Kotler G, Bubes V, Mora S, Tatituri R, Cook NR, Manson JE, Costenbader KH. Joint effects of one year of marine omega-3 fatty acid supplementation and participant dietary fish intake upon circulating lipid mediators of inflammation resolution in a randomized controlled trial. Nutrition. 2024 Jul;123:112413. doi: 10.1016/j.nut.2024.112413. Epub 2024 Feb 28.'}, {'pmid': '38272846', 'type': 'RESULT', 'citation': 'Costenbader KH, Cook NR, Lee IM, Hahn J, Walter J, Bubes V, Kotler G, Yang N, Friedman S, Alexander EK, Manson JE. Vitamin D and Marine n-3 Fatty Acids for Autoimmune Disease Prevention: Outcomes Two Years After Completion of a Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2024 Jun;76(6):973-983. doi: 10.1002/art.42811. Epub 2024 Feb 20.'}, {'pmid': '31699704', 'type': 'RESULT', 'citation': 'Costenbader KH, MacFarlane LA, Lee IM, Buring JE, Mora S, Bubes V, Kotler G, Camargo CA Jr, Manson JE, Cook NR. Effects of One Year of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Biomarkers of Systemic Inflammation in Older US Adults. Clin Chem. 2019 Dec;65(12):1508-1521. doi: 10.1373/clinchem.2019.306902. Epub 2019 Nov 7.'}, {'pmid': '32583982', 'type': 'RESULT', 'citation': 'MacFarlane LA, Cook NR, Kim E, Lee IM, Iversen MD, Gordon D, Buring JE, Katz JN, Manson JE, Costenbader KH. The Effects of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Chronic Knee Pain in Older US Adults: Results From a Randomized Trial. Arthritis Rheumatol. 2020 Nov;72(11):1836-1844. doi: 10.1002/art.41416. Epub 2020 Oct 3.'}, {'pmid': '35082139', 'type': 'RESULT', 'citation': 'Hahn J, Cook NR, Alexander EK, Friedman S, Walter J, Bubes V, Kotler G, Lee IM, Manson JE, Costenbader KH. Vitamin D and marine omega 3 fatty acid supplementation and incident autoimmune disease: VITAL randomized controlled trial. BMJ. 2022 Jan 26;376:e066452. doi: 10.1136/bmj-2021-066452.'}], 'seeAlsoLinks': [{'url': 'http://www.vitalstudy.org/', 'label': 'Welcome to the VITAL Study Website'}]}, 'descriptionModule': {'briefSummary': 'The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among VITAL participants and will examine whether vitamin D or fish oil have effects upon A) autoimmune disease incidence, B) biomarkers of systemic inflammation, and C) chronic knee pain. Blood samples at baseline and in follow-up will be collected in a randomly selected subcohort of 1500 individuals and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein, interleukin-6, and tumor necrosis factor-receptor 2. Approximately 1300 individuals with chronic, frequent knee pain will be followed with annual questionnaires to evaluate the effects of the supplements on chronic knee pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'As for the parent trial, VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259). Individuals with chronic, frequent knee pain at study baseline will be followed as a subcohort. Trial enrollment complete.'}, 'identificationModule': {'nctId': 'NCT01351805', 'acronym': 'VITAL', 'briefTitle': 'Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain', 'orgStudyIdInfo': {'id': 'R01AR059086', 'link': 'https://reporter.nih.gov/quickSearch/R01AR059086', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01AR059086', 'link': 'https://reporter.nih.gov/quickSearch/R01AR059086', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish Oil', 'description': 'Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]).', 'interventionNames': ['Drug: Fish Oil', 'Other: placebo pill']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.', 'interventionNames': ['Dietary Supplement: Vitamin D', 'Other: placebo pill']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Subjects will receive placebo pill.', 'interventionNames': ['Other: placebo pill']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D and Fish Oil', 'description': 'Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]).', 'interventionNames': ['Drug: Fish Oil', 'Dietary Supplement: Vitamin D']}], 'interventions': [{'name': 'Fish Oil', 'type': 'DRUG', 'otherNames': ['eicosapentaenoic acid (EPA)', 'docosahexaenoic acid (DHA)', 'marine fatty acids', 'omega-3 fatty acids', 'fish oils'], 'description': 'Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \\[EPA\\] and 375 mg of docosahexaenoic acid \\[DHA\\]).', 'armGroupLabels': ['Fish Oil', 'Vitamin D and Fish Oil']}, {'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol', 'vitamin D3'], 'description': 'Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.', 'armGroupLabels': ['Vitamin D', 'Vitamin D and Fish Oil']}, {'name': 'placebo pill', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Fish Oil', 'Vitamin D', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Karen H Costenbader, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Physician', 'investigatorFullName': 'Karen H. Costenbader', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}