This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

A long-term seal- and cod-liver-oil supplementation in hypercholesterolemic subjects.



Key Questions Addressed
1 RCTs and other Comparative studies
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title A long-term seal- and cod-liver-oil supplementation in hypercholesterolemic subjects.
Author zz_Brox J., Olaussen K., Osterud B., Elvevoll EO., Bjørnstad E., Brattebøg G., Iversen H.
Country Department of Clinical Chemistry, University Hospital of Tromsø, Norway. klkjjb@rito.no
Year 2001
Numbers Pubmed ID: 11214732
14781 (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) Seal oil
  • Comments Comments (
    0
    ) |
2 "Fish oil" (DHA+EPA) Cod liver oil
  • Comments Comments (
    0
    ) |
3 No intervention
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
  • Comments Comments (
    0
    ) |
Country in which study conducted (where subjects live) Norway
  • Comments Comments (
    0
    ) |
Funding source Authors report industry affiliation
  • Comments Comments (
    0
    ) |
Eligibility Criteria: Serum cholesterol 7.0–9.5 mmol/L (270–366 mg/dL), clinically healthy, and no lipid-lowering drugs
  • Comments Comments (
    0
    ) |
Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
  • Comments Comments (
    0
    ) |
Comment about study design: The study was double blinded for the groups given the dietary oils. No placebo was given in the control group, and the study of this group could thus not be blinded to test subjects or investigators.
  • Comments Comments (
    0
    ) |
Duration of Intervention 14 months
  • Comments Comments (
    0
    ) |
At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... serum cholesterol 7.0–9.5 mmol/L (270–366 mg/dL)
  • Comments Comments (
    0
    ) |
Does the study report a subgroup analysis for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Study start date(s) 1999 (Approx)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100
  • Comments Comments (
    0
    ) |
serum cholesterol 270–366 mg/dL
  • Comments Comments (
    0
    ) |
Baseline characteristics, continuous nd nd nd 55
  • Comments Comments (
    0
    ) |
8.2 8.3 nd 43,66
  • Comments Comments (
    0
    ) |
mmol/L mmol/L nd
  • Comments Comments (
    0
    ) |
0.9 0.8 69.8
  • Comments Comments (
    0
    ) |
1.3 1.3 Kg
  • Comments Comments (
    0
    ) |
mmol/L mmol/L 10.2
  • Comments Comments (
    0
    ) |
0.3 0.4 nd
  • Comments Comments (
    0
    ) |
72.6 70.8 nd
  • Comments Comments (
    0
    ) |
Kg Kg nd
  • Comments Comments (
    0
    ) |
13.6 13.6 nd
  • Comments Comments (
    0
    ) |
nd nd nd
  • Comments Comments (
    0
    ) |
nd nd nd
  • Comments Comments (
    0
    ) |
nd nd
  • Comments Comments (
    0
    ) |
nd nd
  • Comments Comments (
    0
    ) |
nd nd
  • Comments Comments (
    0
    ) |
nd nd
  • Comments Comments (
    0
    ) |
Male, percent nd nd nd 50
  • Comments Comments (
    0
    ) |
Race nd
  • Comments Comments (
    0
    ) |
Comments about baseline data No data entered.
Baseline diet description nd nd nd
  • Comments Comments (
    0
    ) |
Baseline omega-3 intake average 1–2 fish meals per week average 1–2 fish meals per week average 1–2 fish meals per week
  • Comments Comments (
    0
    ) |
Does this study report baseline omega-3 biomarker data? Yes
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: lipid      Population: 44413
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention


4 months

N Analyzed 38 38 37
Mean 186 177 186
SD 97 79 79
SE


10 months

N Analyzed 38 38 37
Mean 195 203 195
SD 88 115 88
SE


14 months

N Analyzed 38 38 37
Mean 168 195 195
SD 79 124 79
SE
Outcome: lipid      Population: 44414
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention


14 months

N Analyzed 38 38 37
Mean 1.4 1.3 nd
SD 0.3 0.4 nd
SE

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) nd
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA) nd
No intervention nd

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Unsure
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? Unsure
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? HIGH No placebo was given in the control group, and the study of this group could thus not be blinded to test subjects or investigators.
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? No No placebo was given in the control group, and the study of this group could thus not be blinded to test subjects or investigators.
  • Comments Comments (
    0
    ) |
Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
  • Comments Comments (
    0
    ) |
Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
  • Comments Comments (
    0
    ) |
INTENTION-TO-TREAT analysis? (Yes/No) Yes
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**GENERAL**) LOW
  • Comments Comments (
    0
    ) |
Was there incomplete COMPLIANCE with interventions across groups? Unsure
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**OMEGA-3**) Yes
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table.
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |

Quality Rating
Guideline Used Overall Rating