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

Tracking Information

First Received Date ^ICMJE

November 27, 2012

Last Updated Date

November 27, 2012

Start Date ^ICMJE

November 2012

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertriglyceridemia

Intervention ^ICMJE

Dietary Supplement: DHA-O
Dietary Supplement: Fish oil
Dietary Supplement: Placebo

Study Arm (s)

Experimental: DHA-O
Intervention: Dietary Supplement: DHA-O
Active Comparator: Fish oil
Intervention: Dietary Supplement: Fish oil
Placebo Comparator: Placebo
Intervention: Dietary Supplement: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Ryan Childers

Ryan.Childers@mxns.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01737099

Other Study ID Numbers ^ICMJE

2012-1048

Has Data Monitoring Committee

Responsible Party

DSM Nutritional Products, Inc.

Study Sponsor ^ICMJE

DSM Nutritional Products, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kevin Maki, PhD

Biofortis Clinical Research

Information Provided By

DSM Nutritional Products, Inc.

Verification Date

November 2012

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

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