Omega-3 Fatty Acid Supplementation in Children

The Hospital for Sick Children

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Hypertriglyceridemia

Treatments: Dietary Supplement: n-3 Fatty Acid supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01088776

1000012569

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

Supplement

Experimental group

Treatment:

Dietary Supplement: n-3 Fatty Acid supplement

Control

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo