Omega-3 Fatty Acid Supplementation in Children
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|ClinicalTrials.gov Identifier: NCT01088776|
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Hypertriglyceridemia||Dietary Supplement: n-3 Fatty Acid supplement Dietary Supplement: Placebo||Phase 2|
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|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01088776
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Donna Secker, PhD, RD||The Hospital for Sick Children|