Clinical trial NCT00672633: Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides
Official title: A Double Blind Randomized Controlled Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Keywords: Omega 3 Fatty Acids
Triglycerides
Lovaza
Trial
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-05-06
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting Triglycerides
timeFrame: 3 months
Secondary outcomes:
measure: LDL Cholesterol
timeFrame: 3 months
measure: HDL Cholesterol
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Stavroula K Osganian, MD, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Sara DeFerranti, MD
role: PRINCIPAL_INVESTIGATOR
References: