Efficacy and Safety Study of DHA-O in Adults With Hypertr... | NCT01737099

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

NCT01737099

Sponsor

dsm-firmenich Switzerland AG

Status

Completed

Last Update Posted

Apr 25, 2014Estimated

Enrollment

93Actual

Phase

Not Applicable

Conditions

Hypertriglyceridemia

Interventions

DHA-O
Fish oil
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Nov 27, 2012

First Submission Date that Met QC Criteria

Nov 27, 2012

First Posted Date

Nov 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2014

Last Update Posted Date

Apr 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DHA-O	Dietary Supplement		DHA-O
Fish oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in TG levels		week 14

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in lipid panel measures		week 14

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Maki, PhD	Biofortis Clinical Research, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biofortis Clinical Research		Addison	Illinois	60101	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25123060	Derived	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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D009821	Oils
D008055	Lipids