NCT01737099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

November 27, 2012

Last Update Submit

April 24, 2014

Conditions

Hypertriglyceridemia

Keywords

omega-3DHAtriglycerideslipidscardiovascularhypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in TG levels

    week 14

Secondary Outcomes (1)

  • Change from baseline in lipid panel measures

    week 14

Study Arms (3)

DHA-O

EXPERIMENTAL
Dietary Supplement: DHA-O

Fish oil

ACTIVE COMPARATOR
Dietary Supplement: Fish oil

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

DHA-ODIETARY_SUPPLEMENT
DHA-O
Fish oilDIETARY_SUPPLEMENT
Fish oil
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 18-79
  • fasting TG levels, 150-499 mg/dL
  • baseline DHA intake \<200mg/d
  • active and in good health

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

Related Publications (1)

  • 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.

    PMID: 25123060DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Kevin Maki, PhD

    Biofortis Clinical Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

US(1)