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Omega-3 Fatty Acid Supplementation in Children

Primary Purpose

Chronic Kidney Disease, Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
n-3 Fatty Acid supplement
Placebo
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD, hypertriglyceridemia, Fatty Acid Supplementation, Children, Omega-3

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supplement

Control

Arm Description

Outcomes

Primary Outcome Measures

Fasting Blood Lipid Profiles(TG levels)

Secondary Outcome Measures

Platelet aggregation
CBC
Cholesterol Levels (LDL and HDL)
Tolerability of n-3 fatty acid supplements by our participants
Sustainability of TG-lowering effects up to 4 weeks after stopping supplements

Full Information

First Posted
March 16, 2010
Last Updated
October 19, 2016
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01088776
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertriglyceridemia
Keywords
CKD, hypertriglyceridemia, Fatty Acid Supplementation, Children, Omega-3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplement
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 Fatty Acid supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Fasting Blood Lipid Profiles(TG levels)
Time Frame
Week 1,4,12,16,24 and 28
Secondary Outcome Measure Information:
Title
Platelet aggregation
Time Frame
Week 1,4,12,16,24 and 28
Title
CBC
Time Frame
Week 1,4,12,16,24 and 28
Title
Cholesterol Levels (LDL and HDL)
Time Frame
Week 1,4,12,16,24 and 28
Title
Tolerability of n-3 fatty acid supplements by our participants
Description
Sustainability of TG-lowering effects up to 4 weeks after stopping supplements
Time Frame
Week 1,4,12,16,24 and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Secker, PhD, RD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Omega-3 Fatty Acid Supplementation in Children

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