Fish Oil Study for High Triglyceride Levels in Children

NCT ID: NCT00915902

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Omega-3-acid ethyl esters

Intervention Type: DRUG

Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks

Interventions

Omega-3-acid ethyl esters

Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks

Intervention Type: DRUG

Placebo

Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Lovaza; Corn Oil

Eligibility Criteria

Inclusion Criteria

• Male or female patients who are 10-17 years of age
• Fasting triglyceride level >150 mg/dl and < 750 mg/dl measured on 2 separate occasions.
• Ability to follow the study procedures and adhere to the diet counseling recommendations
• Written parental permission and assent are obtained prior to any research procedures

Exclusion Criteria

• Bleeding disorders
• Diabetes mellitus (impaired glucose tolerance is not an exclusion)
• Uncontrolled hypothyroidism
• Liver disease
• Allergy to fish/shellfish
• Patients requiring chronic use of aspirin and non-steroidal anti-inflammatory agents
• Patients requiring lipid lowering agents
• LDL-Cholesterol levels >160 mg/dl
• Current participation in another clinical study or within the previous 30 days
• Alcohol use
• Currently pregnant or planning to become pregnant during the course of this trial (confirmed by pregnancy testing)
• Any significant medical condition which the investigator believes would interfere with the patient's ability to safely participate in this trial

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

Babu Balagopal

OTHER

Sponsor Role: lead

Responsible Party

Babu Balagopal

Principal Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samuel Gidding, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours

Locations

A. I. duPont Hospital for Children

Wilmington, Delaware, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Thomas Jefferon University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

GIDDING

Identifier Type: -

Identifier Source: org_study_id