CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 1 target
Drug / intervention
fish oil supplementdietary
Likely dose
Not stated in record
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Search/NCT04327713
NCT04327713N/AUnknown

Systematic Review and Meta-analysis of Randomized Controlled Trials of the Effect of Fish Oil Supplementation on Cardiovascular Outcomes in Diabetes

University of Toronto·observational·Posted Mar 31, 2020·Updated Nov 4, 2020

In Brief

An observational study evaluating fish oil supplement for Type2 Diabetes and 5 related conditions. Targeting 1 participant across 1 site.

Detailed Summary

Fish oil contains a large amount of long-chain omega-3 polyunsaturated fatty acids, which are considered an important component of a healthy diet. As many patients do not eat fish, supplementation with fish oil is a common strategy to provide sufficient amounts of these particular fatty acids in daily life. Fish oil supplementation has been investigated for decades for its cardio-protective effects and its ability to lower serum triglycerides. People with diabetes mellitus have an increased risk for cardiovascular events and show alterations in lipids with high triglycerides. Whether there is a benefit of fish oil supplementation in this high risk group remains unclear with major international diabetes associations recommending against the use of fish oil supplements. The European Association for the Study of Diabetes (EASD) has not made any recommendations about the use of fish oils in people with diabetes since 2004. To inform the update of the EASD clinical practice guidelines for nutrition therapy, the Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned the proposed systematic review and meta-analysis of randomized controlled trials of the effect of fish oil supplementation on cardiovascular outcomes in people with diabetes and use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence.

Study Details

Timeline

N/AUnknownOverdue
202120222023202420252026
First PostedMar 31, 2020
Enrollment StartMar 28, 2020
Primary CompletionMar 1, 2021
Study CompletionApr 1, 2021
TodayJul 1, 2026
Enrollment to primary: 11 monthsPosted 6.3 years ago

Interventions

fish oil supplementdietary

daily fish oil supplement vs. placebo