Omega-3 Fatty Acid Supplementation in Children

NCT01088776 | Completed Phase 2

• 1 other identifier: 1000012569
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Hypertriglyceridemia

Keywords

CKD; hypertriglyceridemia; Fatty Acid Supplementation; Children; Omega-3

Outcome Measures

Primary Outcomes (1)

• Fasting Blood Lipid Profiles(TG levels)

  Week 1,4,12,16,24 and 28

Secondary Outcomes (4)

• Platelet aggregation

  Week 1,4,12,16,24 and 28

• CBC

  Week 1,4,12,16,24 and 28

• Cholesterol Levels (LDL and HDL)

  Week 1,4,12,16,24 and 28

• Tolerability of n-3 fatty acid supplements by our participants

  Week 1,4,12,16,24 and 28

Study Arms (2)

Supplement

EXPERIMENTAL

Dietary Supplement: n-3 Fatty Acid supplement

Control

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

n-3 Fatty Acid supplement DIETARY_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.

Supplement

Placebo DIETARY_SUPPLEMENT

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.

Control

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Donna Secker, PhD, RD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

CA (1)