Fish Oil Study for High Triglyceride Levels in Children
|Hypertriglyceridemia||Drug: Omega-3-acid ethyl esters Drug: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents|
- Change in Triglyceride Level [ Time Frame: after 8 week treatment or placebo period ]
|Study Start Date:||July 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Omega-3-acid ethyl esters (Lovaza)
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).
Drug: Omega-3-acid ethyl esters
Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks
Other Name: Lovaza
Placebo Comparator: Placebo
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.
Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks
Other Name: Corn Oil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915902
|United States, Delaware|
|A. I. duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Pennsylvania|
|Thomas Jefferon University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Samuel Gidding, MD||Nemours|