Omega-3 Fatty Acid Supplementation in Children
|Chronic Kidney Disease Hypertriglyceridemia||Dietary Supplement: n-3 Fatty Acid supplement Dietary Supplement: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease|
- Fasting Blood Lipid Profiles(TG levels) [ Time Frame: Week 1,4,12,16,24 and 28 ]
- Platelet aggregation [ Time Frame: Week 1,4,12,16,24 and 28 ]
- CBC [ Time Frame: Week 1,4,12,16,24 and 28 ]
- Cholesterol Levels (LDL and HDL) [ Time Frame: Week 1,4,12,16,24 and 28 ]
- 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
|Study Start Date:||March 2010|
|Study Completion Date:||March 2016|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088776
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Donna Secker, PhD, RD||The Hospital for Sick Children|