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Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

Primary Purpose

Hypertriglyceridemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lovaza

Placebo

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Omega 3 Fatty Acids, Triglycerides, Lovaza, Trial

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A , Experimental

Corn Oil Pill

Arm Description

Lovaza, 4 grams/day orally for 6 months

Corn Oil Pill, 4 pills/day orally for 6 months

Outcomes

Primary Outcome Measures

Fasting Triglycerides

Secondary Outcome Measures

LDL Cholesterol

Low Density Lipoprotein Cholesterol

HDL Cholesterol

High Density Lipoprotein Cholesterol

Full Information

NCT ID

NCT00672633

First Posted

April 30, 2008

Last Updated

May 24, 2013

Sponsor

Boston Children's Hospital

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00672633

Brief Title

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

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Terminated

Why Stopped

Very slow recruitment.

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

Keywords

Omega 3 Fatty Acids, Triglycerides, Lovaza, Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A , Experimental

Arm Type

Experimental

Arm Description

Lovaza, 4 grams/day orally for 6 months

Arm Title

Corn Oil Pill

Arm Type

Placebo Comparator

Arm Description

Corn Oil Pill, 4 pills/day orally for 6 months

Intervention Type

Drug

Intervention Name(s)

Lovaza

Intervention Description

Lovaza , 4 grams/day orally for 6 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Corn Oil Pill

Intervention Description

Corn Oil Pill, 4 pills/day orally for 6 months

Primary Outcome Measure Information:

Title

Fasting Triglycerides

Description

Fasting Triglycerides

Time Frame

3 months

Secondary Outcome Measure Information:

Title

LDL Cholesterol

Description

Low Density Lipoprotein Cholesterol

Time Frame

3 months

Title

HDL Cholesterol

Description

High Density Lipoprotein Cholesterol

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stavroula K Osganian, MD, ScD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sara DeFerranti, MD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

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Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

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