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Study Title and Description

Comparison of the effects of simultaneous administration of vitamin C and omega-3 fatty acids on lipoproteins, apo A-I, apo B, and malondialdehyde in hyperlipidemic patients.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Comparison of the effects of simultaneous administration of vitamin C and omega-3 fatty acids on lipoproteins, apo A-I, apo B, and malondialdehyde in hyperlipidemic patients.
Author Shidfar F., Keshavarz A., Jallali M., Miri R., Eshraghian M.
Country Laboratory of Biochemistry, Department of Nutrition and Biochemistry, School of Health, Tehran University of Medical Sciences. farzadshidfar@yahoo.com
Year 2003
Numbers Pubmed ID: 12847992
15269 (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 placebo of n-3 and placebo of vitamin C
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2 Placebo 500 mg vitamin C + placebo of n-3
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3 "Fish oil" (DHA+EPA) 1g n-3 + placebo of vitamin C
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4 "Fish oil" (DHA+EPA) 1g n-3 + 500 mg vitamin C
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Iran
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: Entry criteria included a serum total cholesterol and triglyceride > 200 mg/dl; body mass index <30; and no recent symptomatic diabetes, thyroid, liver, or renal disease. Patients taking sex hormones, diuretics, thyroid medications, corticosteroids, anti-hypertensives, vitamin C, oral contraceptive agents, and any medications that might interfere with the evaluation of results were excluded.
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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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Comment about study design:
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Duration of Intervention 10 weeks
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... serum total cholesterol and triglyceride > 200 mg/dl;
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Does the study report a subgroup analysis for an outcome of interest? No
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Study start date(s) 2001 (approx)
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Baseline Characteristics
Question Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100% 100% 100% 100% 100%
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Baseline characteristics, continuous 54.4 51.8 54.4 58.9 nd
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skip skip 11.7 skip
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12.2 10.7 26.9 7
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27.6 27.8 skip 26.4
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skip skip 2.2 skip
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3 2.9 74.3 2.6
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72 79 Kg 69.9
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Kg Kg 10.2 Kg
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10.8 8.7 nd 12
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nd nd nd nd
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nd nd nd nd
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nd nd 243.4 nd
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250.7 243.5 mg/dL 236.7
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mg/dL mg/dL 36.9 mg/dL
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46.3 35.3 159.6 49.9
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167.4 160.6 mg/dL 150.8
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mg/dL mg/dL 45.4 mg/dL
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38.2 41.5 39.1 47.4
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39.2 37.2 mg/dL 53.3
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mg/dL mg/dL 9.6 mg/dL
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9.3 5.6 304 10.4
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311.5 315 mg/dL 297.3
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mg/dL mg/dL 88.4 mg/dL
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100.2 98 74.1
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Male, percent 36.8% 35.3% 31.25% 31.25%
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Race nd nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd nd nd nd
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Baseline omega-3 intake nd nd nd nd nd
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Does this study report baseline omega-3 biomarker data? No No No No No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 45133
Time Point Measure Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 19 17 16 16
Mean 39.2 37.2 39.1 53.3
SD 9.3 5.6 9.6 10.4
SE




N Analyzed
Mean
SD
SE


10 weeks

N Analyzed 19 17 16 16
Mean 37.4 34 37 35.2
SD 9.9 5.7 10.3 7.6
SE
Outcome: lipid      Population: 45134
Time Point Measure Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 19 17 16 16
Mean 167.4 160.6 159.6 150.8
SD 38.2 41.5 45.4 47.4
SE


10 weeks

N Analyzed 19 17 16 16
Mean 169.3 140.8 157.3 141.3
SD 48.2 30.5 50 46.8
SE
Note Mean corrected from "69.3" Mean corrected from "41.3"
Outcome: lipid      Population: 45135
Time Point Measure Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 19 17 16 16
Mean 4.42 4.3 4.2 4.4
SD 1.2 0.9 1.4 1.7
SE


10 weeks

N Analyzed 19 17 16 16
Mean 4.93 4.2 4.4 4.51
SD 2.1 1 1.9 2.8
SE
Outcome: lipid      Population: 45136
Time Point Measure Placebo Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 19 17 16 16
Mean 311.5 315 304 297.3
SD 100.2 98 88.4 74.1
SE


10 weeks

N Analyzed 19 17 16 16
Mean 328.3 279.1 211.7 276.6
SD 132.7 99.4 78.4 72.2
SE

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

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? No Data no randomization method mentioned
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Was ALLOCATION adequately concealed (prior to assignment)? No Data
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Were PARTICIPANTS adequately BLINDED? Yes double blinded
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Were OUTCOME ASSESSORS adequately BLINDED? Yes
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Yes
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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) Unsure
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? No Data
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Group SIMILARITY AT BASELINE (**OMEGA-3**) No Data
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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.