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Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia (DHA-O)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737099
First Posted: November 29, 2012
Last Update Posted: April 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.
November 27, 2012
November 29, 2012
April 25, 2014
November 2012
November 2013   (Final data collection date for primary outcome measure)
Change from baseline in TG levels [ Time Frame: week 14 ]
Same as current
Complete list of historical versions of study NCT01737099 on ClinicalTrials.gov Archive Site
Change from baseline in lipid panel measures [ Time Frame: week 14 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
Not Provided
The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Dietary Supplement: DHA-O
  • Dietary Supplement: Fish oil
  • Dietary Supplement: Placebo
  • Experimental: DHA-O
    Intervention: Dietary Supplement: DHA-O
  • Active Comparator: Fish oil
    Intervention: Dietary Supplement: Fish oil
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
November 2013
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ages 18-79
  • fasting TG levels, 150-499 mg/dL
  • baseline DHA intake <200mg/d
  • active and in good health

Exclusion Criteria:

  • recent diagnosis of CHD or history of revascularization within 6mos of study
  • 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
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01737099
2012-1048
No
Not Provided
Not Provided
DSM Nutritional Products, Inc.
DSM Nutritional Products, Inc.
Not Provided
Principal Investigator: Kevin Maki, PhD Biofortis Clinical Research, Inc.
DSM Nutritional Products, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP