Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

A Double Blind Randomized Controlled Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides.

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.

Study Overview

• Status: Terminated
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: Lovaza; Drug: Placebo

Detailed Description

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.
• To determine the effects of LOVAZA on plasma HDL and LDL cholesterol at 3 months and 6 months.
• To determine the effects of LOVAZA on systolic and diastolic blood pressure at 3 months and 6 months.

2.3 Exploratory Aims

• To describe the effects of LOVAZA on vascular reactivity/endothelial function as measured by pulse amplitude at 3 months and 6 months.
• To describe the effects of LOVAZA on levels of biomarkers of inflammation as measured by C-Reactive Protein at 3 months and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 10-19 years old
• Fasting Triglyceride levels of 150-1000 mg/dl at the screening and baseline visit
• Ability to swallow pills
• Informed consent from a parent or legal guardian of minors or adult subject
• Written assent from the adolescent to participate in the study
• English or Spanish speaking

Exclusion Criteria:

• Food Allergy to Fish or any components of the pills which includes alpha tocopherol, partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol or corn oil, and iron oxide or iron oxide containing food color additives.
• Pregnancy or positive urine pregnancy test for those females who have begun menstruating
• Breast feeding
• Alcohol Use: Patient is unable to abstain from alcohol use during the study. This will be assessed by asking the following questions: "During the past 30 days, on how many days did you have at least one drink of alcohol?"; "During the past 30 days, on how many days did you have 5 or more drinks of alcohol in a row, that is, within a couple of hours?"; "This study requires that you abstain from alcohol use during the course of the study. Do you think you can do this?"
• Known Bleeding Disorder or Coagulopathy or treatment with anticoagulant medications or low platelet counts, abnormal PT, or PTT.
• Significant cognitive or psychosocial disorder or medical illness that would limit participation in the trial.
• Type 1 or 2 Diabetes or fasting glucose that is >=126 mg/dl
• Liver disease or an ALT greater than 2 times upper limit of normal
• Treatment with medications that affect triglyceride levels, including oral hypoglycemic agents or insulin.
• Be currently taking the same oral contraceptive pills for less than the past three months or intend to change or discontinue prescription oral contraceptive pills used in the next seven months
• Be currently taking any over-the-counter supplements that affect triglycerides or lipid metabolism including over the counter fish oil supplements.
• Treatment for or diagnosis of a thyroid disorder or an elevated TSH level at baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A , Experimental; Lovaza, 4 grams/day orally for 6 months	Drug: Lovaza; Lovaza , 4 grams/day orally for 6 months
Placebo Comparator: Corn Oil Pill; Corn Oil Pill, 4 pills/day orally for 6 months	Drug: Placebo; Corn Oil Pill, 4 pills/day orally for 6 months; Other Names: Corn Oil Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Triglycerides	Fasting Triglycerides	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL Cholesterol	Low Density Lipoprotein Cholesterol	3 months
HDL Cholesterol	High Density Lipoprotein Cholesterol	3 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Stavroula K Osganian, MD, ScD, Boston Children's Hospital; Principal Investigator: Sara DeFerranti, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: April 30, 2008
• First Submitted That Met QC Criteria: May 5, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 24, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Trial; Triglycerides; Lovaza; Omega 3 Fatty Acids
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: 08010028