Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
NCT ID: NCT01737099
Last Updated: 2014-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2012-11-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DHA-O
DHA-O
Fish oil
Fish oil
Placebo
Placebo
Interventions
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DHA-O
Fish oil
Placebo
Eligibility Criteria
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Inclusion Criteria
* fasting TG levels, 150-499 mg/dL
* baseline DHA intake \<200mg/d
* active and in good health
Exclusion Criteria
* use of lipid altering medications (other than stable statins)
* use of anticoagulants
* use of omega-3 products within 4 weeks of screening
* serum AST/ALT \>1.5x ULN and/or creatinine \>1.5 mg/dL at screening
* lipid altering foods or supplements
* women who are pregnant or of childbearing potential not using adequate birth control
* current use or history of drug or alcohol abuse
* inability to swallow capsules
18 Years
79 Years
ALL
Yes
Sponsors
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DSM Nutritional Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Maki, PhD
Role: PRINCIPAL_INVESTIGATOR
Biofortis Clinical Research, Inc.
Locations
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Biofortis Clinical Research
Addison, Illinois, United States
Countries
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References
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Maki KC, Yurko-Mauro K, Dicklin MR, Schild AL, Geohas JG. A new, microalgal DHA- and EPA-containing oil lowers triacylglycerols in adults with mild-to-moderate hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2014 Oct;91(4):141-8. doi: 10.1016/j.plefa.2014.07.012. Epub 2014 Jul 22.
Other Identifiers
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2012-1048
Identifier Type: -
Identifier Source: org_study_id
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