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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01737099

Acronym

DHA-O

Enrollment

Registered

2012-11-29

Start date

2012-11-30

Completion date

2013-11-30

Last updated

2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

omega-3, DHA, triglycerides, lipids, cardiovascular, hypertriglyceridemia

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.

Interventions

DIETARY_SUPPLEMENTDHA-O

DIETARY_SUPPLEMENTFish oil

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in TG levels	week 14

Secondary

Measure	Time frame
Change from baseline in lipid panel measures	week 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026