Clinical trial NCT01088776: Omega-3 Fatty Acid Supplementation in Children
Official title: Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Hypertriglyceridemia
Keywords: CKD
hypertriglyceridemia
Fatty Acid Supplementation
Children
Omega-3
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 4
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Fasting Blood Lipid Profiles(TG levels)
timeFrame: Week 1,4,12,16,24 and 28
Secondary outcomes:
measure: Platelet aggregation
timeFrame: Week 1,4,12,16,24 and 28
measure: CBC
timeFrame: Week 1,4,12,16,24 and 28
measure: Cholesterol Levels (LDL and HDL)
timeFrame: Week 1,4,12,16,24 and 28
measure: Tolerability of n-3 fatty acid supplements by our participants
timeFrame: Week 1,4,12,16,24 and 28
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Donna Secker, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: