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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(®) 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(®) REVEAL Trial.
Author Shaikh NA., Yantha J., Shaikh S., Rowe W., Laidlaw M., Cockerline C., Ali A., Holub B., Jackowski G.
Country University of Toronto, 6190 Tremaine court, Mississauga, ON, L5V 1B5, Canada, nshaikh6190@rogers.com.
Year 2014
Numbers Pubmed ID: 25185754

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 corn oil
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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 REVEAL Trial
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Country in which study conducted (where subjects live) Canada
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Funding source No Data on funding or affiliations
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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 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, Healthy
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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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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Hypertension ...
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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? 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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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 10.7 14.8
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32.1 31.5
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Baseline characteristics, continuous 53.4 53.8
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skip skip
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92.5 nd
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skip nd
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5 93.6
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mmol/L skip
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3.2 4.6
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mmol/L mmol/L
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1.05 2.7
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mmol/L mmol/L
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2.3 1.1
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mmol/L mmol/L
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31.7 2.2
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skip mmol/L
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nd 32.1
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nd skip
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nd nd
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Male, percent 58.9% 48.1%
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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 3.465 median omega-score 3.375 median omega-score
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Does this study report baseline omega-3 biomarker data? No No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 59647
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 59648
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed
Mean
SD
SE


8 weeks

N Analyzed
Mean
SD
SE
Outcome: lipid      Population: 59649
Time Point Measure "Fish oil" (DHA+EPA) Placebo


0 weeks

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) Adverse Event 1 fishy burp 3 56 8 weeks
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Placebo 0 54 8 weeks
"Fish oil" (DHA+EPA) Adverse Event 1 flatulation 2 56 8 weeks
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Placebo 0 54 8 weeks
"Fish oil" (DHA+EPA) Adverse Event 1 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 HIGH ~32% lost to follow up
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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 only analyzed patients that had follow up data
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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. 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
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Quality Rating
No quality rating data was found.