Omega-3 Fatty Acid Supplementation in Children

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Hypertriglyceridemia
• Interventions: Dietary Supplement: n-3 Fatty Acid supplement; Dietary Supplement: Placebo

• Registration Number: NCT01088776
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Primary Completion: 2012-02
• Study Completion: 2016-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplement	n-3 Fatty Acid supplement	-
Control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Fasting Blood Lipid Profiles(TG levels)	Week 1,4,12,16,24 and 28

Secondary Outcome Measures

Name	Time	Method
Platelet aggregation	Week 1,4,12,16,24 and 28
CBC	Week 1,4,12,16,24 and 28
Cholesterol Levels (LDL and HDL)	Week 1,4,12,16,24 and 28
Tolerability of n-3 fatty acid supplements by our participants	Week 1,4,12,16,24 and 28	Sustainability of TG-lowering effects up to 4 weeks after stopping supplements

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada