- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088776
Omega-3 Fatty Acid Supplementation in Children
Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
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.
|
Experimental: Supplement
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting Blood Lipid Profiles(TG levels)
Time Frame: Week 1,4,12,16,24 and 28
|
Week 1,4,12,16,24 and 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet aggregation
Time Frame: Week 1,4,12,16,24 and 28
|
Week 1,4,12,16,24 and 28
|
|
CBC
Time Frame: Week 1,4,12,16,24 and 28
|
Week 1,4,12,16,24 and 28
|
|
Cholesterol Levels (LDL and HDL)
Time Frame: Week 1,4,12,16,24 and 28
|
Week 1,4,12,16,24 and 28
|
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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
|
Week 1,4,12,16,24 and 28
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donna Secker, PhD, RD, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000012569
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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