Text Size

Omega-3 Fatty Acid Supplementation in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01088776
First received: March 16, 2010
Last updated: June 21, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Hypertriglyceridemia
 Dietary Supplement: n-3 Fatty Acid supplement
Dietary Supplement: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Supplementation to Treat Hypertriglyceridemia in Children With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Fasting Blood Lipid Profiles(TG levels) [ Time Frame: Week 1,4,12,16,24 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Platelet aggregation [ Time Frame: Week 1,4,12,16,24 and 28 ] [ Designated as safety issue: No ]
  • CBC [ Time Frame: Week 1,4,12,16,24 and 28 ] [ Designated as safety issue: No ]
  • Cholesterol Levels (LDL and HDL) [ Time Frame: Week 1,4,12,16,24 and 28 ] [ Designated as safety issue: No ]
  • Tolerability of n-3 fatty acid supplements by our participants [ Time Frame: Week 1,4,12,16,24 and 28 ] [ Designated as safety issue: No ]
    Sustainability of TG-lowering effects up to 4 weeks after stopping supplements


Estimated Enrollment: 24
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplement 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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088776

Contacts
Contact: Donna Secker, PhD, RD 416-813-6605 donna.secker@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Principal Investigator: Donna Secker, PhD, RD            
Sub-Investigator: Elizabeth Harvey, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Donna Secker, PhD, RD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Donna Secker, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01088776     History of Changes
Other Study ID Numbers: 1000012569
Study First Received: March 16, 2010
Last Updated: June 21, 2010
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
CKD
hypertriglyceridemia
Fatty Acid Supplementation
Children
Omega-3

Additional relevant MeSH terms:
Hypertriglyceridemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperlipidemias
 Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013