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Study Title and Description

Omega-3 fatty acid supplements improve the cardiovascular risk profile of subjects with metabolic syndrome, including markers of inflammation and auto-immunity.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Omega-3 fatty acid supplements improve the cardiovascular risk profile of subjects with metabolic syndrome, including markers of inflammation and auto-immunity.
Author Ebrahimi M., Ghayour-Mobarhan M., Rezaiean S., Hoseini M., Parizade SM., Farhoudi F., Hosseininezhad SJ., Tavallaei S., Vejdani A., Azimi-Nezhad M., Shakeri MT., Rad MA., Mobarra N., Kazemi-Bajestani SM., Ferns GA.
Country Heart and Vascular Research Centre, Avicenna (Bu-Ali) Research Institute, MUMS, Mashhad, Iran.
Year 2009
Numbers Pubmed ID: 19593941
15599 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) Each omega-3 fatty acid capsule contained 180mg EPA and 120mg DHA.
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2 No intervention not given supplements
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Iran
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: with metabolic syndrome but had not previously taken n-3 fatty acid capsules or other nutritional supplements. People who were <40 or >70 years old were excluded from the study.
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Duration of Intervention 6 months
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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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) 2007 (Approx)
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100 100
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Baseline characteristics, continuous 53.5 52.3
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skip skip
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12.7 11.1
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130.7 129.6
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14.7 skip
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81.7 19.8
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9.7 78.3
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ND skip
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5.99 13.4
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mmol/L 5.75
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1.07 mmol/L
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3.77 1.04
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mmol/L 3.71
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0.89 mmol/L
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1.18 0.72
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mmol/L 1.12
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0.15 mmol/L
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mmol/L 0.19
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1.76 5.75
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1.16-2.24 IQR mmol/L
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30.3 1.04
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skip 30.4
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5.2 skip
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68.3 6.1
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Kg 69.5
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11.7 Kg
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14.6
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Male, percent nd nd nd
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Race nd nd nd
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Comments about baseline data No data entered.
Baseline diet description ND ND
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Baseline omega-3 intake ND ND
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Does this study report baseline omega-3 biomarker data? No No No
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Results & Comparisons


Results Data
Outcome: bp      Population: 45714
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 47 42
Mean 130.7 123.6
SD 14.7 23.7


6 months

N Analyzed 47 42
Mean 129.6 127.8
SD 19.8 16.8
Outcome: bp      Population: 45715
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 47 42
Mean 81.7 78.3
SD 9.7 13.4


6 months

N Analyzed 47 42
Mean 81.2 82.3
SD 9 9.1
Outcome: lipid      Population: 45716
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 47 42
Mean 1.18 1.12
SD 0.15 0.19


6 months

N Analyzed 47 42
Mean 1.23 1.18
SD 0.16 0.11
Outcome: lipid      Population: 45717
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 47 42
Mean 3.77 3.71
SD 0.89 0.72


6 months

N Analyzed 47 42
Mean 2.98 2.78
SD 0.79 0.74
Outcome: lipid      Population: 45718
Time Point Measure "Fish oil" (DHA+EPA) No intervention


0 months

N Analyzed 47 42
Median 1.76 1.64
25th Percentile 1.16 1.06
75th Percentile 2.24 2.20


6 months

N Analyzed 47 42
Median 1.45 1.41
25th Percentile 1.04 0.96
75th Percentile 2.06 2.29

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? No Data no randomization method mentioned
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Was ALLOCATION adequately concealed (prior to assignment)? No Data
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Were PARTICIPANTS adequately BLINDED? No Data
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Were OUTCOME ASSESSORS adequately BLINDED? Yes lab test for lipids. blood pressure was measured by standard mercury sphygmomanometer.
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data No Data
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) No Data
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? No Data
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Group SIMILARITY AT BASELINE (**OMEGA-3**) No Data
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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.