NCT00915902

Fish Oil Study for High Triglyceride Levels in Children

Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Babu Balagopal · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Omega-3-acid ethyl esters	Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks
DRUG	Placebo	Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-06-08
• Last updated: 2022-11-08
• Results posted: 2014-05-07

Locations

3 sites across 1 country: United States