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Study Title and Description

A controlled trial of the effect of linolenic acid on incidence of coronary heart disease. The Norwegian vegetable oil experiment of 1965-66.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title A controlled trial of the effect of linolenic acid on incidence of coronary heart disease. The Norwegian vegetable oil experiment of 1965-66.
Author Natvig H., Borchgrevink CF., Dedichen J., Owren PA., Schiotz EH., Westlund K.
Country -- Not Found --
Year 1968
Numbers Pubmed ID: 5756076
MA03-34 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo
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2 ALA
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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) The Norwegian Vegetable Oil Experiment of 1965-66
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Country in which study conducted (where subjects live) Norway
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Funding source Industry funded
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Eligibility Criteria: Eligibility: male patients of industrial physicians working part time in Norway. Exclusion criteria: none
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Study Population Primary Prevention, Healthy
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Duration of Intervention 1 year
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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) 1965
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Baseline Characteristics
Question Placebo ALA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 0.134% 0.149%
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Baseline characteristics, continuous (49,61) (49,61) Kg
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(60,90+)
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Male, percent 100% 100%
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Race nd nd
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Comments about baseline data Baseline Diseases/Conditions include Angina Pectoris: 0.179% of participants Baseline Diseases/Conditions include Angina Pectoris: 0.283% of participants
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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
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Results & Comparisons


Results Data
Outcome: Death      Population: 52380
Time Point Measure Placebo ALA


1 years

N Enrolled 6690 6716
Counts 40 43




N Enrolled
Counts
Outcome: cardiac      Population: 52391
Time Point Measure Placebo ALA


1 years

N Enrolled
Counts
Outcome: cardiac      Population: 52391
Time Point Measure Placebo ALA


1 years

N Enrolled 122 116
Counts 9 10
Outcome: cardiac      Population: 52391
Time Point Measure Placebo ALA


1 years

N Enrolled 216 236
Counts 2 12
Outcome: cardiac      Population: 52391
Time Point Measure Placebo ALA


1 years

N Enrolled 6352 6364
Counts 52 53
Outcome: cardiac      Population: 52392
Time Point Measure Placebo ALA


1 years

N Enrolled 6627 6641
Counts 12 19
Outcome: cerebro      Population: 52393
Time Point Measure Placebo ALA


1 years

N Enrolled 6690 6716
Counts 9 12

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? Unsure participants distributed by "simple randomization"
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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? High The reviewers were aware whether a man belonged to one of the oil groups.
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data High For followup of 1 year, percentage of withdrawals and drop-outs exceeded 20%.
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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**) Unsure
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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 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.