Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Metabolic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 5/3/2014 |
| Start Date: | November 2012 |
| End Date: | June 2013 |
| Contact: | Ryan Childers |
| Email: | Ryan.Childers@mxns.com |
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.
elevated triglyceride levels in healthy adults with hypertriglyceridemia.
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
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