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Study Title and Description

A randomized clinical trial on n-3 polyunsaturated fatty acids supplementation and all-cause mortality in elderly men at high cardiovascular risk.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title A randomized clinical trial on n-3 polyunsaturated fatty acids supplementation and all-cause mortality in elderly men at high cardiovascular risk.
Author Einvik G., Klemsdal TO., Sandvik L., Hjerkinn EM.
Country Division of Medicine, Akershus University Hospital, Lørenskog, Norway. gunnar.einvik@medisin.uio.no
Year 2010
Numbers Pubmed ID: 20389249
16826 (internal)

Secondary Publication Information
UI Title Author Country Year
Serum levels of interleukin-18 are reduced by diet and n-3 fatty acid intervention in elderly high-risk men. Trøseid M., Arnesen H., Hjerkinn EM., Seljeflot I. Center for Clinical Heart Research, Ullevål Department of Cardiology, Oslo University Hospital, University of Oslo, N-0407 Oslo, Norway. 2009
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Effect of diet or very long chain omega-3 fatty acids on progression of atherosclerosis, evaluated by carotid plaques, intima-media thickness and by pulse wave propagation in elderly men with hypercholesterolaemia. Hjerkinn EM., Abdelnoor M., Breivik L., Bergengen L., Ellingsen I., Seljeflot I., Aase O., Ole Klemsdal T., Hjermann I., Arnesen H. Centre for Clinical Research, Ullevaal University Hospital, Oslo, Norway. elsah.jerkinn@ulleval.no 2006
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) with or without dietary intervention
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2 Placebo with or without dietary intervention
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3 Placebo no diet intervention
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4 Placebo diet intervention
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5 "Fish oil" (DHA+EPA) no diet intervention
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6 "Fish oil" (DHA+EPA) diet intervention
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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What is the name of this study? (e.g. DART, Physician's Health Study) DOIT
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Country in which study conducted (where subjects live) Norway
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: The basis for recruitment in the DOIT was the 910 survivors from a population of 1232 healthy men with hypercholesterolemia (> 6.45 mmol/l) participating in the Oslo Diet and Antismoking Study, carried out from 1972 to 1977. Exclusion factors in the DOIT were: total cholesterol greater than 8mmol/l, blood pressure levels greater than 170/100mmHg, specific disease states or practical causes thought to influence longevity, or compliance (cancer, end-stage renal failure, chronic alcoholism or travel distance>200km).
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Comment about Eligibility Criteria: A total of 82 individuals were excluded and 10 individuals were unwilling to participate.
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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 3 years
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... hypercholesterolemia (> 6.45 mmol/l)
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... history of CVD
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Study start date(s) 1997
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 15 14 15 14 13 13
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20 19 32 26 31 32
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treated hyperlipidemia treated hyperlipidemia treated hypertension treated hypertension treated hypertension treated hypertension
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27 29 18 18 17 18
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treated hypertension treated hypertension
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Baseline characteristics, continuous 70.4 69.7 69 70 70 70
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149 3.0 64, 75 65, 75 64, 75 65, 75
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17 148 147 149 150 149
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nd 19 20 19 18 18
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6.3 nd 83 82 83 85
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mmol/L 6.2 11 11 12 11
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1.0 mmol/L nd nd nd nd
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4.1 1.0 6.3 6.2 6.4 6.3
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mmol/L 4.0 mmol/L mmol/L mmol/L mmol/L
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1.0 mmol/L 1.0 1.0 1.0 1.1
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1.4 0.9 4.1 4.0 4.2 1.4
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mmol/L 1.4 mmol/L mmol/L mmol/L mmol/L
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0.4 mmol/L 1.0 0.9 1.0 0.3
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1.7 0.4 1.4 1.4 1.4 4.1
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mmol/L 1.7 mmol/L mmol/L mmol/L mmol/L
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0.8 mmol/L 0.4 0.4 0.4 1.0
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26.3 0.9 1.7 1.7 1.7 1.7
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3.2 26.7 mmol/L mmol/L mmol/L mmol/L
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nd 3.7 0.9 0.9 0.8 0.8
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nd 26.6 26.8 26.5 26.5
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3.7 3.8 3.4 3.5
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Male, percent 100 100
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Race nd nd nd nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description nd
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: Death      Population: 51884
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


3 years

N Enrolled 282 281 nd nd nd nd
Counts 14 24 nd nd nd nd
Outcome: death      Population: 51885
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


3 years

N Enrolled 282 281 nd nd nd nd
Counts 7 11 nd nd nd nd
Outcome: composite      Population: 51887
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


3 years

N Enrolled 282 281 nd nd nd nd
Counts 32 36 nd nd nd nd
Outcome: lipid      Population: 51888
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 years

N Analyzed 282 281 68 71 70 69
Median 1.6 1.5 nd nd nd nd
25th Percentile 1.1 1.1 nd nd nd nd
75th Percentile 2.1 2.0 nd nd nd nd
Mean nd nd 1.71 1.74 1.72 1.75
SD nd nd 0.9 0.9 0.8 0.8


3 years

N Analyzed 247 239 56 58 63 59
Median 1.1 1.4 nd nd nd nd
25th Percentile 0.9 1.0 nd nd nd nd
75th Percentile 1.7 1.9 nd nd nd nd
Mean nd nd 1.60 1.49 1.44 1.27
SD nd nd 0.9 0.8 0.8 0.6
Outcome: lipid      Population: 51893
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 years

N Analyzed nd nd 68 71 70 69
Mean nd nd 1.43 1.43 1.42 1.40
SD nd nd 0.41 0.39 0.39 0.32


3 years

N Analyzed nd nd 56 58 63 59
Mean nd nd 1.44 1.54 1.50 1.53
SD nd nd 0.35 0.47 0.39 0.37
Outcome: lipid      Population: 51895
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 years

N Analyzed nd nd 68 71 70 69
Mean nd nd 4.7 4.6 4.8 4.8
SD nd nd 1.4 1.2 1.4 1.2


3 years

N Analyzed nd nd 56 58 63 59
Mean nd nd 4.6 4.3 4.4 4.2
SD nd nd 1.2 1.2 1.4 1.2
Outcome: bp      Population: 51897
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 years

N Analyzed nd nd 56 58 63 59
Mean nd nd 148 149 150 149
SD nd nd 19 19 18 17


3 years

N Analyzed nd nd 68 71 70 69
Mean nd nd 143 142 143 141
SD nd nd 19 21 16 19
Outcome: bp      Population: 51898
Time Point Measure "Fish oil" (DHA+EPA) Placebo Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 years

N Analyzed nd nd 68 71 70 69
Mean nd nd 83 83 83 85
SD nd nd 11 11 11 11


3 years

N Analyzed nd nd 56 58 63 59
Mean nd nd 79 77 79 78
SD nd nd 12 12 11 12

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) regurgitation 4% of participants in the n-3 group 11 282 3 years
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Placebo 0 281 3 years
Placebo
Placebo
"Fish oil" (DHA+EPA)
"Fish oil" (DHA+EPA)

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW
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Was ALLOCATION adequately concealed (prior to assignment)? UNCLEAR
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Were PARTICIPANTS adequately BLINDED? LOW Low for N-3 vs placebo; high for dietary intervention
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Were OUTCOME ASSESSORS adequately BLINDED? LOW Low for N-3 vs placebo; high for dietary intervention
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
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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) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? LOW
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Group SIMILARITY AT BASELINE (**OMEGA-3**) LOW
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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.