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

Complementary effects of multivitamin and omega-3 fatty acid supplementation on indices of cardiovascular health in individuals with elevated homocysteine.



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

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Complementary effects of multivitamin and omega-3 fatty acid supplementation on indices of cardiovascular health in individuals with elevated homocysteine.
Author Earnest CP., Kupper JS., Thompson AM., Guo W., Church T.
Country Department for Health, Sport, Health and Exercise Science, University of Bath, UK. c.p.earnest@bath.ac.uk
Year 2012
Numbers Pubmed ID: 22811376
15200 (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
  • Comments Comments (
    0
    ) |
2 "Fish oil" (DHA+EPA) fish oil
  • Comments Comments (
    0
    ) |
3 "Fish oil" (DHA+EPA) fish oil + multivitamin
  • Comments Comments (
    0
    ) |
4 Placebo placebo + multivitamin
  • 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) US
  • Comments Comments (
    0
    ) |
Funding source No Data on funding or affiliations
  • Comments Comments (
    0
    ) |
Eligibility Criteria: Inclusion criteria for this study necessitated that participants have a HCY concentration > 8.0 u mol/L. We excluded pregnant or lactating women from participation. Postmenopausal women both on and off hormone replacement therapy were accepted into the trial. We asked those on hormone replacement therapy to remain on their current medication and dosage schedule and notify us if the regimen was changed. Participants currently on standard medical therapy (for conditions such as hypertension, hypercholesterolemia, diabetes, arthritis, or other chronic diseases) were allowed to enter the study if they had been taking any medications for at least 6 months and agreed to remain on their current therapy during the trial.
  • Comments Comments (
    0
    ) |
Study Population Primary Prevention, Healthy
  • Comments Comments (
    0
    ) |
Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
  • Comments Comments (
    0
    ) |
Duration of Intervention 12 weeks
  • Comments Comments (
    0
    ) |
At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
  • Comments Comments (
    0
    ) |
Hypertension ...
  • Comments Comments (
    0
    ) |
Dyslipidemia ...
  • Comments Comments (
    0
    ) |
Does the study report a subgroup analysis for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Study start date(s) 2009 (Approx)
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous nd nd nd nd 52.9
  • Comments Comments (
    0
    ) |
nd nd nd nd 10.7
  • Comments Comments (
    0
    ) |
nd nd nd nd 26.3
  • Comments Comments (
    0
    ) |
nd nd nd nd 4.4
  • Comments Comments (
    0
    ) |
4.77 nd 5.39 5.10 80.7
  • Comments Comments (
    0
    ) |
mmol/L nd mmol/L mmol/L Kg
  • Comments Comments (
    0
    ) |
0.99 5.47 1.14 0.83 17.4
  • Comments Comments (
    0
    ) |
2.72 mmol/L 3.36 3.10 30, 70
  • Comments Comments (
    0
    ) |
mmol/L 0.96 mmol/L mmol/L
  • Comments Comments (
    0
    ) |
0.83 3.42 0.93 0.74
  • Comments Comments (
    0
    ) |
1.48 mmol/L 1.43 1.41
  • Comments Comments (
    0
    ) |
mmol/L 0.79 mmol/L mmol/L
  • Comments Comments (
    0
    ) |
0.51 1.48 0.51 0.41
  • Comments Comments (
    0
    ) |
1.25 mmol/L 1.31 1.28
  • Comments Comments (
    0
    ) |
mmol/L 0.49 mmol/L mmol/L
  • Comments Comments (
    0
    ) |
0.57 1.25 0.83 0.70
  • Comments Comments (
    0
    ) |
nd mmol/L nd nd
  • Comments Comments (
    0
    ) |
nd 0.70 nd nd
  • Comments Comments (
    0
    ) |
Male, percent nd nd nd nd 55%
  • Comments Comments (
    0
    ) |
Race nd nd nd nd 77
  • Comments Comments (
    0
    ) |
13
  • Comments Comments (
    0
    ) |
0
  • Comments Comments (
    0
    ) |
10
  • Comments Comments (
    0
    ) |
0
  • Comments Comments (
    0
    ) |
Comments about baseline data No data entered.
Baseline diet description No data entered.
Baseline omega-3 intake ALA 1.4g, EPA 0.1g, DHA 0.1g ALA 1.0g, EPA 0.1g, DHA 0.1g ALA 1.1g, EPA 0.0g, DHA 0.1g ALA 1.1g, EPA 0.1g, DHA 0.1g
  • Comments Comments (
    0
    ) |
Does this study report baseline omega-3 biomarker data? No No No No
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: lipid      Population: 45193
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


0 weeks

N Analyzed 23 21 25 23
Mean 1.25 1.25 1.31 1.28
SD 0.57 0.70 0.83 0.70


12 weeks

N Analyzed 23 21 25 23
95% CI low -0.35 -0.14 -0.45 -0.11
95% CI high 0.17 -0.69 -0.95 0.42
Change in Mean -0.1 -0.41 -0.70 0.15

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Placebo nd
  • Comments Comments (
    0
    ) |
"Fish oil" (DHA+EPA)
"Fish oil" (DHA+EPA)
Placebo

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? LOW
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? LOW
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? LOW
  • 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) No
  • 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**) LOW
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table. LOW
  • 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 LOW
  • 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 LOW
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.