Fish Oil Study for High Triglyceride Levels in Children

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samuel Gidding
• Collaborators: GlaxoSmithKline; Johns Hopkins University; Thomas Jefferson University

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