Hypertriglyceridemia Clinical Trial
Official title:
A Double Blind Randomized Controlled Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides.
Verified date | May 2013 |
Source | Children's Hospital Boston |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | March 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 19 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Boston | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fasting Triglycerides | Fasting Triglycerides | 3 months | No |
Secondary | LDL Cholesterol | Low Density Lipoprotein Cholesterol | 3 months | No |
Secondary | HDL Cholesterol | High Density Lipoprotein Cholesterol | 3 months | No |
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