Omega-3 Fatty Acid Supplementation in Children

Following counseling on dietary and lifestyle changes to lower triglyceride levels, and a period of applying these modifications, children will be assigned in a random fashion to take either fish oil supplements or a placebo (soybean/corn oil) for 8 weeks. After this 8-week treatment period, children will not take a supplement for 4 weeks and then will be assigned the alternate product (fish oil or placebo) for another 8 weeks. Our main interest is to see whether there is a larger decrease in triglyceride levels after taking the fish oil supplement compared to the placebo.

The primary objective of this study is to determine whether omega-3 fatty acid supplements, given at therapeutic dosages over an 8-week period, significantly decrease elevated serum TG in children with CKD;

The secondary objectives of this study are:

i. To evaluate the effect of n-3 fatty acid supplements on total-, LDL-, and HDL-cholesterol;

ii. To determine whether n-3 fatty acid supplements are well tolerated by our study participants; and

iii. To test whether TG-lowering effects are sustained up to 4 weeks after stopping supplements.

Inclusion criteria

• age at randomization: 2.0-17.4 years old (stratified by age: 2-8 yr, 9-13 yr, 14-17.4 yr)
• CKD stages 3 or 4 (GFR:15-59 ml/min/1.73 m2)
• established and stable in the CKD 3 and 4 Program for a minimum of 3 months
• fasting serum TG 95th percentile for age and gender 2 on more than or equal to 2 occasions

Exclusion criteria

• allergy to fish, corn, soybean
• anti-coagulant or anti-platelet drugs (heparin, warfarin, therapeutic NSAIDs) or herbal products (ginko, garlic, feverfew, ginger and ginseng) known to prolong bleeding
• currently undergoing treatment for dyslipidemia
• use of dietary supplements containing n-3FA
• children with Nephrotic Syndrome, on dialysis, or transplanted
• planned surgery, dialysis or transplantation within the next 7 months
• children with diabetes
• bleeding and clotting disorders:

• thrombocytopenia (platelet count <100 x 109/L), including ITP, TTP
• Von Willebrands disease
• hemophilia
• thrombophilia
• vitamin K deficiency
• severe liver disease
• unstable patients with shock which can lead to DIC (disseminated intravascular coagulation)
• active Henoch Schonlein Purpura
• hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber disease)