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Study Title and Description

Supplementation with omega3 polyunsaturated fatty acids and all-rac alpha-tocopherol alone and in combination failed to exert an anti-inflammatory effect in human volunteers.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Supplementation with omega3 polyunsaturated fatty acids and all-rac alpha-tocopherol alone and in combination failed to exert an anti-inflammatory effect in human volunteers.
Author zz_Vega-López S., Kaul N., Devaraj S., Cai RY., German B., Jialal I.
Country Laboratory for Atherosclerosis and Metabolic Research, University of California, Davis, Medical Center, Sacramento, CA, USA.
Year 2004
Numbers Pubmed ID: 14767877
15270 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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Country in which study conducted (where subjects live) US
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Funding source Authors report industry affiliation
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No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: Healthy, ages 20-55 Excluded if: smoking; diabetes; antioxidant or vitamin supplementation; consumption of more than 1 meal of fish per week or n3PUFA supplements within the past 5 months; chronic disease or gastrointestinal problems; bleeding diathesis; abnormal complete blood cell count or renal, liver, or thyroid function; alcohol intake greater than 1 oz/d; use of hypolipidemic drugs, thyroid drugs, nonsteroidal anti-inflammatory drugs, or anticoagulants; chronic high-intensity exercise; or postmenopausal
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Study Population Primary Prevention, Healthy
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Duration of Intervention 12 weeks
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Does the study report a subgroup analysis for an outcome of interest? No
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Study start date(s) 2002 (Approx)
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Baseline Characteristics
Question Total Comments
AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous No data entered.
Male, percent No data entered.
Race No data entered.
Comments about baseline data No data entered.
Baseline diet description No data entered.
Baseline omega-3 intake No data entered.
Does this study report baseline omega-3 biomarker data? No data entered.



Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated?
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Was ALLOCATION adequately concealed (prior to assignment)?
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Were PARTICIPANTS adequately BLINDED?
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Were OUTCOME ASSESSORS adequately BLINDED?
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)?
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INTENTION-TO-TREAT analysis? (Yes/No)
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Group SIMILARITY AT BASELINE (**GENERAL**)
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Was there incomplete COMPLIANCE with interventions across groups?
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Group SIMILARITY AT BASELINE (**OMEGA-3**)
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes
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Quality Rating
No quality rating data was found.