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

NCT02201160 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-07-25

No results posted yet for this study

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.

Conditions

  • Non Alcoholic Fatty Liver Disease (NAFLD)

Interventions

DIETARY_SUPPLEMENT

omega 3

Two groups from our cohort will be supplemented either with omega-3 PUFA or placebo during 3 months. Each subject will take 4 capsules/d. after 3 months, the subjects under omega-3 will continue for another 3 months and the group under placebo will take omega-3 PUFA during another 3 months.

Sponsors & Collaborators

  • Nutrisanté Canada

    collaborator UNKNOWN

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Emile Levy, Professor · Research Centre, CHU STe-Justine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201160 on ClinicalTrials.gov