Omega-3 Fatty Acid Supplementation in Children

Chronic Kidney Disease Clinical Trial

Official title:

Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088776
• Other study ID #: 1000012569
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2010
• Last updated: October 19, 2016
• Start date: March 2010
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 2016
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertriglyceridemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Blood Lipid Profiles(TG levels)		Week 1,4,12,16,24 and 28	No
Secondary	Platelet aggregation		Week 1,4,12,16,24 and 28	No
Secondary	CBC		Week 1,4,12,16,24 and 28	No
Secondary	Cholesterol Levels (LDL and HDL)		Week 1,4,12,16,24 and 28	No
Secondary	Tolerability of n-3 fatty acid supplements by our participants	Sustainability of TG-lowering effects up to 4 weeks after stopping supplements	Week 1,4,12,16,24 and 28	No