Omega-3 Fatty Acid Supplementation in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01088776
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Elizabeth Harvey, 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hypertriglyceridemia Dietary Supplement: n-3 Fatty Acid supplement Dietary Supplement: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease
Study Start Date : March 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Supplement Dietary Supplement: n-3 Fatty Acid supplement

Children will be prescribed 1600-1800 mg EPA + DHA per m2 Body Surface Area, to a maximum of the upper limit of the age-appropriate range recommended by Health Canada.

Each n-3FA gel capsule (1000 mg) will contain 400 mg EPA and 200 mg DHA derived from the oil of wild anchovies and sardines. A smaller gel capsule (500 mg; 200 mg EPA + 100 mg DHA) will be available for children unable to swallow large solid medication and a flavored liquid formulation, containing a similar proportion of EPA + DHA (2200 mg fish oil concentrate from anchovies and sardines, 750 mg EPA, 375 mg DHA per ½ teaspoon), will be available for use in toddlers and older children unable to swallow gel capsules.

Placebo Comparator: Control Dietary Supplement: Placebo
The placebo, identical in opaque appearance and citrus-flavored taste, will contain a 50:50 blend of soybean and corn oil for both gel capsule (2 sizes) and liquid formulations.

Primary Outcome Measures :
  1. Fasting Blood Lipid Profiles(TG levels) [ Time Frame: Week 1,4,12,16,24 and 28 ]

Secondary Outcome Measures :
  1. Platelet aggregation [ Time Frame: Week 1,4,12,16,24 and 28 ]
  2. CBC [ Time Frame: Week 1,4,12,16,24 and 28 ]
  3. Cholesterol Levels (LDL and HDL) [ Time Frame: Week 1,4,12,16,24 and 28 ]
  4. Tolerability of n-3 fatty acid supplements by our participants [ Time Frame: Week 1,4,12,16,24 and 28 ]
    Sustainability of TG-lowering effects up to 4 weeks after stopping supplements

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088776

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Donna Secker, PhD, RD The Hospital for Sick Children

Responsible Party: Elizabeth Harvey, Nephrologist, The Hospital for Sick Children Identifier: NCT01088776     History of Changes
Other Study ID Numbers: 1000012569
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Elizabeth Harvey, The Hospital for Sick Children:
Fatty Acid Supplementation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Lipid Metabolism Disorders
Metabolic Diseases