Omega-3 Fatty Acid Supplementation in Children
Condition: Chronic Kidney Disease; Hypertriglyceridemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): n-3 Fatty Acid supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CKD; hypertriglyceridemia; Fatty Acid Supplementation; Children; Omega-3