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

Hypertriglyceridemia Clinical Trial

— DHA-O  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737099
• Other study ID #: 2012-1048
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: April 24, 2014
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Dietary Supplement:
• DHA-O

• Fish oil

• Placebo

Locations

Country	Name	City	State
United States	Biofortis Clinical Research	Addison	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in TG levels		week 14	No
Secondary	Change from baseline in lipid panel measures		week 14	No