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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier:
NCT01737099
First received: November 27, 2012
Last updated: April 24, 2014
Last verified: April 2014

November 27, 2012
April 24, 2014
November 2012
November 2013   (final data collection date for primary outcome measure)
Change from baseline in TG levels [ Time Frame: week 14 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   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
Both
18 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01737099
2012-1048
No
DSM Nutritional Products, Inc.
DSM Nutritional Products, Inc.
Not Provided
Principal Investigator: Kevin Maki, PhD Biofortis Clinical Research
DSM Nutritional Products, Inc.
April 2014

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