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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.
  Purpose
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.

Condition Intervention
Hypertriglyceridemia Dietary Supplement: DHA-O Dietary Supplement: Fish oil Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by DSM Nutritional Products, Inc.:

Primary Outcome Measures:
  • Change from baseline in TG levels [ Time Frame: week 14 ]

Secondary Outcome Measures:
  • Change from baseline in lipid panel measures [ Time Frame: week 14 ]

Enrollment: 93
Study Start Date: November 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA-O Dietary Supplement: DHA-O
Active Comparator: Fish oil Dietary Supplement: Fish oil
Placebo Comparator: Placebo Dietary Supplement: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737099


Locations
United States, Illinois
Biofortis Clinical Research
Addison, Illinois, United States, 60101
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Kevin Maki, PhD Biofortis Clinical Research, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT01737099     History of Changes
Other Study ID Numbers: 2012-1048
First Submitted: November 27, 2012
First Posted: November 29, 2012
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by DSM Nutritional Products, Inc.:
omega-3
DHA
triglycerides
lipids
cardiovascular
hypertriglyceridemia

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases