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

NCT02201160 | Unknown Phase 1 DMC

• 1 other identifier: NAFLD-2188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

NAFLD; Fatty acid composition; Omega 3 supplementation; Metabolism

Outcome Measures

Primary Outcomes (1)

• Efficacy of omega 3 PUFA supplementation in NAFLD subjects compared to placebos

  Two groups from our cohort will be double blind supplemented either with n-3 PUFA or sun flower (as a placebo). The specific primary outcome is to assess the activities of hepatic plasma transaminase enzymes (ALT/AST/GGT) in the omega 3 group and to determine their decrease to the normal range.

  24 weeks

Secondary Outcomes (1)

• A composite mesures regarding the improvement of metabolic profile of NAFLD patients

  24 weeks

Other Outcomes (1)

• Short term versus long-term treatment comparison

  12 weeks vs. 24 weeks

Study Arms (2)

omega 3

ACTIVE COMPARATOR

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).

Dietary Supplement: omega 3

Sun Flower

PLACEBO COMPARATOR

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.

Dietary Supplement: omega 3

Interventions

omega 3 DIETARY_SUPPLEMENT

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.

Sun Flower; omega 3

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• boys (according to the literature review on NAFLD prevalence)
• body weight ≥ 95th percentile (based on the CDC Chart)
• aged \<18 years
• have a diffusely hyperechogenic liver at ultrasonography (consistent with NAFLD diagnostic)
• have normal or high transaminases (\> 2N).

You may not qualify if:

• Subjects with pin or cochlear implants
• Subjects who consumed natural medicine products
• Those in whom a surgical procedure was planned
• the child who were found to consume fish, flaxseed oil and foods enriched with n-3 PUFA (eggs, or milk containing n-3 PUFA supplements), probiotics, vitamin E or use of drugs known to induce fatty liver during the study.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Nutrisanté Canada: collaborator

Study Sites (1)

CHU Ste-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

• Belanger SA, Vanasse M, Spahis S, Sylvestre MP, Lippe S, L'heureux F, Ghadirian P, Vanasse CM, Levy E. Omega-3 fatty acid treatment of children with attention-deficit hyperactivity disorder: A randomized, double-blind, placebo-controlled study. Paediatr Child Health. 2009 Feb;14(2):89-98. doi: 10.1093/pch/14.2.89.

  PMID: 19436468 BACKGROUND

• Spahis S, Alvarez F, Ahmed N, Dubois J, Jalbout R, Paganelli M, Grzywacz K, Delvin E, Peretti N, Levy E. Non-alcoholic fatty liver disease severity and metabolic complications in obese children: impact of omega-3 fatty acids. J Nutr Biochem. 2018 Aug;58:28-36. doi: 10.1016/j.jnutbio.2018.03.025. Epub 2018 Apr 10.

  PMID: 29864682 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Emile Levy, Professor

  Research Centre, CHU STe-Justine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor and researcher

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 25, 2014
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

CA (1)