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Study Title and Description

Effect of low doses of long-chain n-3 PUFAs on endothelial function and arterial stiffness: a randomized controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effect of low doses of long-chain n-3 PUFAs on endothelial function and arterial stiffness: a randomized controlled trial.
Author Sanders TA., Hall WL., Maniou Z., Lewis F., Seed PT., Chowienczyk PJ.
Country Diabetes and Nutritional Sciences Division, School of Medicine, King's College London, London, United Kingdom. tom.sanders@kcl.ac.uk
Year 2011
Numbers Pubmed ID: 21865334
14894 (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) EPA+DHA 0.45 g/d
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2 "Fish oil" (DHA+EPA) EPA+DHA 0.9 g/d
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3 "Fish oil" (DHA+EPA) EPA+DHA 1.8 g/d
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4 Placebo olive oil (BP specification)
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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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What is the name of this study? (e.g. DART, Physician's Health Study) MARINA trial
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Country in which study conducted (where subjects live) UK
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: Nonsmokers (confirmed by cotinine testing) men and women aged 45–70 y.Exclusions: a medical history of CVD; overall risk of cardiovascular disease >20% over the next 10 y; cancer (excluding basal cell carcinoma) in the previous 5 y; type 1 DM; uncontrolled type 2 DM; chronic renal, liver, or inflammatory bowel disease; history of substance abuse or alcoholism; pregnancy; weight change of >3 kg in preceding 2 mo; and BMI <20 and >35.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 12 months
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Conflict of interest No conflict of interest (explicitly stated)
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Does the study report a subgroup analysis for an outcome of interest? No
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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) 2008
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 55 55 55 55
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121 95%CI (54, 56) 95%CI (54, 57) 95%CI (54, 57)
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77 122 121 120
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nd 95%CI (119, 125) 95%CI (117, 124) 95%CI (117, 124)
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nd 78 76 77
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nd 95%CI (76, 80) 95%CI (75, 78) 95%CI (75, 79)
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nd nd nd nd
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nd nd nd nd
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25 (women); 26 (men) nd nd nd
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nd nd nd nd
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95%CI (53, 56) nd nd nd
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95%CI (118, 124) 26 (women); 27(men) 25 (women); 26 (men) 26 (women); 27(men)
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95%CI (75, 79) 95%CI (24, 27); 95%CI (26, 28) 95%CI (24, 26); 95%CI (25, 27) 95%CI (25, 27); 95%CI (26, 28)
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95%CI (24, 26); 95%CI (25, 27) nd nd nd
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Male, percent 38.3 38.7 39.1 38.6
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Race 80.9 78.5 85.9 77.3
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4.3 6.5 1.1 10.2
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6.4 10.8 2.2 6.8
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Far Eastern: 4.3 Other: 3.4 Far Eastern: 0 Other: 4.3 Far Eastern: 4.3 Other: 6.5 Far Eastern: 2.3 Other: 3.4
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Comments about baseline data Although no baseline omega-3 biomarker data, the net changes in RBC EPA and DHA (delta wt% vs. placebo) were reported in Figure 2.
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Baseline diet description The proportion of energy derived from total fatty acids, saturated fatty acids, and PUFAs was similar to that of the general population as reported in the rolling UK National Dietary and Nutritional Surveys.
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Baseline omega-3 intake nd nd nd nd dietary assessment method was not reported
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Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons


Results Data
Outcome: bp      Population: 49398
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


run-in N/A

N Analyzed 80 79 80 71
Mean 93 94 91 93
95% CI low 90 91 88 90
95% CI high 95 96 93 95


1 years

N Analyzed 80 79 80 71
Mean 90 92 89 90
95% CI low 88 90 87 88
95% CI high 93 94 91 93
Outcome: bp      Population: 49435
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


run-in N/A

N Analyzed 80 79 80 71
Mean 122.6 123.5 119.1 122.6
95% CI low 120.0 120.4 116.1 120.0
95% CI high 125.2 126.6 122.0 125.2


1 years

N Analyzed 80 79 80 71
Mean 122.1 122.2 118.3 122.1
95% CI low 119.2 119.7 115.6 119.2
95% CI high 125.1 124.8 121.0 125.1
Outcome: bp      Population: 49457
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


run-in N/A

N Analyzed 80 79 80 71
Mean 71.2 73.9 71.8 74.1
95% CI low 69.8 72.3 70.4 72.6
95% CI high 72.7 75.5 73.2 75.7


1 years

N Analyzed 80 79 80 71
Mean 71.2 73.3 71.2 72.9
95% CI low 69.8 72.0 69.9 71.4
95% CI high 72.6 74.6 72.5 74.4

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) nd
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"Fish oil" (DHA+EPA)
"Fish oil" (DHA+EPA)
Placebo

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)? Low
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Were PARTICIPANTS adequately BLINDED? Low
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Were OUTCOME ASSESSORS adequately BLINDED? Low
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Medium slightly more dropouts in placebo group; completer analysis only
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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
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? Low
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Yes
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Additional Bias: Bias due to problems not covered elsewhere in the table. No
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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 Low
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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 Low
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Quality Rating
No quality rating data was found.