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Study Title and Description

Efficacy of a unique omega-3 formulation on the correction of nutritional deficiency and its effects on cardiovascular disease risk factors in a randomized controlled VASCAZEN(registered trademark) REVEAL Trial



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Efficacy of a unique omega-3 formulation on the correction of nutritional deficiency and its effects on cardiovascular disease risk factors in a randomized controlled VASCAZEN(registered trademark) REVEAL Trial
Author zz_Shaikh NAY, J. Shaikh and S. Rowe and W. Laidlaw and M. Cockerline and C. Ali and A. Holub and B. Jackowski and G.
Country
Year 2014
Numbers 15027 (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)
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2 Placebo
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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) VASCAZEN(registered trademark) REVEAL Trial
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Country in which study conducted (where subjects live) US
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Canada
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Funding source Industry funded
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Eligibility Criteria: Male and female study subjects C18 years of age, with one or more risk factor for CVD, were deemed eligible for study enrollment if their fasting whole blood OS levels (OS = blood EPA + DHA + Docosapentaenoic acid) were < 6.1 % by weight of total blood fatty acid levels, and their serum TG was between 1.02 and 5.65 mmol/L. Subjects were excluded from the study if they refused to provide informed consent, had a known allergy to fish, were premenopausal women, were currently taking hormone replacement therapy (HR), lipid-altering medication or LC n- PUFA supplements, had a history of alcohol abuse, were medically ill, had a history of ventricular arrhythmia, bleeding or clotting disorder, liver or kidney disease, autoimmune disorder or suppressed immune systems, myopathy or rhabdomyolysis, seizure disorder, or had an implantable cardioverter defibrillator. Subjects on a stable statin medication for a minimum of three months were eligible to enroll.
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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 8 weeks
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... Subjects were stratified by their baseline fasting TG levels into two Cohorts: Normal TGs (1.02-2.25 mmol/L) and High TGs (2.26-5.65 mmol/l)
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 11 15
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32 31
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Baseline characteristics, continuous mmol/L 53.6
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mmol/L nd
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mmol/L nd
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mmol/L nd
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nd 4.63
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nd mmol/L
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nd 2.70
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53.44 mmol/L
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5.02 1.13
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3.13 mmol/L
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1.06 2.22
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2.28 mmol/L
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31.69 32.1
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Male, percent 59 48
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Race 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 No data entered.
Does this study report baseline omega-3 biomarker data? No data entered.



Results & Comparisons


Results Data
Outcome: lipid      Population: 44714
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44714
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44714
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44715
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44715
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44715
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44716
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44716
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 44716
Time Point Measure "Fish oil" (DHA+EPA) Placebo


Baseline N/A

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) Fishy burp 3 56 8 weeks
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Placebo 0 54 8 weeks
"Fish oil" (DHA+EPA) Flatulence 2 56 8 weeks
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Placebo 0 54 8 weeks
"Fish oil" (DHA+EPA) Nausea 2 56 8 weeks
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Placebo 3 54 8 weeks

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 Low
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Low
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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? High 75% compliance in each arm
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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. 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
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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.