Clinical Trial: Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Double Blind Randomized Controlled Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides.
Brief Summary: The investigators will conduct a randomized clinical trial to evaluate the efficacy of Lovaza (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years old whose baseline triglycerides range from 150 mg/dl to 1000 mg/dl. Seventy subjects will be recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6 months or the control condition, a corn oil placebo, 4 tablets a day for 6 months. Participants in both the treatment and control groups will receive the standard of care, which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet that emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of fishes rich in omega-3 fatty acids, consistent with the American Heart Association recommendations. The primary outcome will be change in fasting triglycerides from baseline to 3 months. The investigators hypothesize that patients who receive LOVAZA will have significantly greater reductions in plasma triglyceride levels when compared to patients on placebo at 3 months.
Detailed Summary:
The investigators propose to conduct a placebo controlled, double blind, parallel group randomized trial to evaluate the efficacy of Lovaza (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years old whose baseline triglycerides range from150 mg/dl to 1000 mg/dl. Seventy subjects will be recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6 months or the control condition, a corn oil placebo, 4 tablets a day for 6 months. Participants in both the treatment and control groups will receive the standard of care, which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet that emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of fishes rich in omega-3 fatty acids, consistent with the American Heart Association recommendations (Kris-Etherton, 2003). Subjects will be randomized to the treatment or control condition after a 4 week run-in period of dietary education and advice. The primary outcome will be change in fasting triglycerides from baseline to 3 months.
2.0 SPECIFIC AIMS
2.1 Primary Aim/Outcome
- To determine the efficacy of LOVAZA in reducing plasma triglyceride levels among adolescents, ages 12-19 years with mild to moderate hypertriglyceridemia. We hypothesize that patients who receive LOVAZA will have significantly greater reductions in plasma triglyceride levels when compared to patients on placebo at 3 months.
2.2 Secondary Aims/Outcome
- To determine whether the efficacy of LOVAZA varies with duration of treatment, 3 months versus 6 months. Sponsor: Boston Children’s Hospital
- LDL Cholesterol [ Time Frame: 3 months ]Low Density Lipoprotein Cholesterol
- HDL Cholesterol [ Time Frame: 3 months ]High Density Lipoprotein Cholesterol
Current Primary Outcome: Fasting Triglycerides [ Time Frame: 3 months ]
Original Primary Outcome: Fasting Triglyceride Levels [ Time Frame: 3 months ]
Current Secondary Outcome:
Original Secondary Outcome: Fasting Triglycerides, blood pressure, HDL and LDL, [ Time Frame: 3 months and 6 months ]
Information By: Boston Children’s Hospital
Dates:
Date Received: April 30, 2008
Date Started: April 2008
Date Completion:
Last Updated: May 24, 2013
Last Verified: May 2013
