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Omega-3 Fatty Acids

Potential Role of n-3 Fatty Acids in the Treatment of NAFLD in Pediatric Patients

Phase 1 & 2
Waitlist Available
Led By Emile Levy, Professor
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks vs. 24 weeks

Summary

Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular carcinoma. It is a common condition associated with a combination of disorders, namely obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS) was mainly studied in the adult population and very little in the paediatric population, while 15 and 25% of obese children are affectés. The severity of histological disease appears to be associated with the degree of obesity in children and particularly in the MetS. in addition, epidemiological data indicate that the incidence of this disease is increasing in children and positioning as the first NASH liver disease in North America. the revelation of the factors associated with the occurrence of NASH is a first necessary step to understanding this disorder worrying for the future of children and adolescents. In addition, clarification of the mechanisms responsible for its development is essential if the investigators want to consider targeted and effective treatments to slow the rat race of NASH, which stands out as the supreme chronic liver accompanying the obesity and MetS. Finally, in view of growth and puberty of children, it would be extremely beneficial to find nutritional avenues that would avoid the side effects of chemical agents.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks vs. 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks vs. 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of omega 3 PUFA supplementation in NAFLD subjects compared to placebos
Secondary study objectives
A composite mesures regarding the improvement of metabolic profile of NAFLD patients
Other study objectives
Short term versus long-term treatment comparison

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: omega 3Active Control1 Intervention
The subjects will take 4 capsules/day during 6 months. Each capsule of the active n-3 PUFA supplement contained 500 mg of fish oil (each capsule provides 300 mg of n-3 PUFA (EPA+DHA) with 3.75 U vitamin E to prevent peroxidation).
Group II: Sun FlowerPlacebo Group1 Intervention
The subjects will take 4 capsules/day during 6 months. The placebo capsule contained 500 mg of sunflower oil with 3.75 U vitamin E.

Find a Location

Who is running the clinical trial?

Nutrisanté CanadaUNKNOWN
St. Justine's HospitalLead Sponsor
200 Previous Clinical Trials
86,210 Total Patients Enrolled
Emile Levy, ProfessorPrincipal InvestigatorResearch Centre, CHU STe-Justine
~2 spots leftby Dec 2025