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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Johns Hopkins University | OTHER |
| Thomas Jefferson University | OTHER |
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High triglyceride levels are increasingly recognized in children, particularly those who are overweight. There are no studies of treatment of high triglycerides in children and adolescents. Fish oil is attractive because it is considered safe and effective for treating high triglycerides in adults and has been used safely for other purposes in children. The investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides, safety, and possible mechanisms of beneficial effects.
Participants (n = 42, age 14 + 2 yrs) with hypertriglyceridemia and LDL cholesterol < 160 mg/dl were enrolled in a randomized double blind cross over trial comparing 4 g fish oil daily with placebo. Treatment interval was 8 weeks with a 4 week wash out, between the two treatment intervals. Lipid profile, lipoprotein particle distribution and size, glucose, insulin, high sensitivity C reactive protien (CRP), interleukin-6, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), and thrombin generation were measured.
Patients were evaluated at 6 time points: Visit 1/baseline (week 0), Visit 2/randomization (week 4), Visit 3/after treatment 1 (week 12) , Visit 4/after wash out (week 16), Visit 5/after treatment 2 (week 24) and Visit 6/close out (week 28) . Patients were advised to maintain a stable diet and not alter baseline fish consumption . One participant took an oral contraceptive throughout the trial. Any fish oil supplements were discontinued. Advice on a heart healthy diet was provided. Blood pressure (right arm sitting with appropriate sized cuff, taken 3 times, last measurement used), height, and weight were measured at the beginning of the study, after the first wash out period, and close out. Participant phone contact was made during each treatment arm to assess diet stability. Fasting lipid profile was performed at every visit. Red blood cell fatty acid profile and secondary endpoints were performed at all visits except baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3-acid ethyl esters (Lovaza) | Experimental | This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. GlaxoSmithKline supplied the study drug and the placebo. The study drug, Omega-3-acid ethyl esters (Lovaza) was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week treatment period. The study drug contained minimally 1.5 g DHA (docosahexaenoic acid) and 1.86 g EPA (eicosapentaenoic acid). |
|
| Placebo | Placebo Comparator | This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. The corn oil placebo was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week non-treatment (placebo) period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3-acid ethyl esters | Drug | Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Triglyceride Level | after 8 week treatment or placebo period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Gidding, MD | Nemours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A. I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States | ||
| Johns Hopkins Hospital |
Patients completed a 4 week dietary run-in prior to randomization at visit 2.
Patients were recruited from Nemours Alfred I. duPont Hospital for Children, Johns Hopkins University and Thomas Jefferson University. Recruitment took place between July 2009 and December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lovaza Then Placebo | Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks |
| FG001 | Placebo Then Lovaza | Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Treatment Period |
| |||||||||||||
| Washout (4 Weeks) |
| |||||||||||||
| 2nd Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Lovaza) Followed by Placebo | Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks |
| BG001 | Placebo Followed by Treatment (Lovaza) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Triglyceride Level | Posted | Mean | Standard Deviation | mg/dL | after 8 week treatment or placebo period |
|
|
During the 20 week duration of the clinical trial. Specifically, during the first 8 week treatment period, the subsequent 4 week washout period, and the following 8 week treatment period.
Adverse Events were only collected and reported during the clinical trial, not after the conclusion of the trial, or prior to its start.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Lovaza) Followed by Placebo, During Treatment | Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| depression, worsening | Psychiatric disorders | Systematic Assessment | hospital stay for depression, worsening. not related to study. |
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Intrinsic variability of triglycerides is large and may have confounded analyses; 4-week washout between treatment periods may have been too short; a reduction of triglycerides in the corn oil placebo group may have compromised the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Nemours Alfred I. duPont Hospital for Children | 302-651-6686 | cprosper@nemours.org |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Drug | Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks |
|
|
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Thomas Jefferon University | Philadelphia | Pennsylvania | 19107 | United States |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Triglyceride (mg/dL | Mean | Standard Deviation | mg/dL |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Treatment (Lovaza) Followed by Placebo, During Placebo | Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout. | 0 | 20 | 0 | 20 |
| EG002 | Placebo Followed by Treatment (Lovaza), During Placebo | Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout. | 0 | 22 | 0 | 22 |
| EG003 | Placebo Followed by Treatment (Lovaza), During Treatment | Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout. | 1 | 22 | 0 | 22 |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |