Fish Oil Study for High Triglyceride Levels in Children

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.

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