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

This study is currently recruiting participants.
Verified November 2012 by DSM Nutritional Products, Inc.
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier:
NCT01737099
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides
Drug Information available for: Fish oil
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from baseline in TG levels [ Time Frame: week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in lipid panel measures [ Time Frame: week 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737099

Contacts
Contact: Ryan Childers Ryan.Childers@mxns.com

Locations
United States, Illinois
Biofortis Clinical Research Recruiting
Addison, Illinois, United States, 60101
Contact: Linda Derrig         Linda.Derrig@mxns.com    
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Kevin Maki, PhD Biofortis Clinical Research
  More Information

No publications provided

Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT01737099     History of Changes
Other Study ID Numbers: 2012-1048
Study First Received: November 27, 2012
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013