omega-3 fatty acid supplementation in children

Conditions: Chronic Kidney Disease; Hypertriglyceridemia

Summary: children with chronic kidney disease (ckd) are at very high risk for cardiovascular morbidity and mortality. hyper-lipidemia, a traditional risk factor for cardiovascular disease (cvd), occurs early in the progression of kidney failure; timely identification and intervention is prudent. currently, there is no known effective therapy for hypertriglyceridemia, the most common lipid abnormality. n-3fa, in doses ranging from 2-6 g/day have effectively lowered elevated triglyceride (tg) levels by 20-50% in a variety of adult populations; however, their use in children with ckd has not been tested in a randomized controlled fashion. this study will provide important information on the safety, efficacy and tolerance of n-3fa in lowering elevated tg levels in children and adolescents with ckd.

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.

Eligibility criteria:
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)

Keywords: ckd hypertriglyceridemia fatty acid supplementation children omega-3