Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver

NCT04281121 | Completed DMC

• 1 other identifier: MD 44/2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

this is a prospective, interventional, open-label, randomized study on the efficacy of omega 3 fatty acids supplementation in Egyptian children with non-alcoholic fatty liver disease who had been selected from nutrition and outpatient clinic at Pediatric hospital, Ain Shams University

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (1)

• grade of fatty liver in children

  improvement

  3 month

Study Arms (2)

supplemented

ACTIVE COMPARATOR

Life style modification, diet regimen and Omega-3 fatty acids supplementation

Dietary Supplement: omega 3 fatty acids

non supplemented

ACTIVE COMPARATOR

Life style modification and diet regimen

Dietary Supplement: omega 3 fatty acids

Interventions

omega 3 fatty acids DIETARY_SUPPLEMENT

: Life style modification, diet regimen and Omega-3 fatty acids supplementation: The dose of omega-3 fatty acids depended on the weight of patients according to World Health Organization recommendations 400 milligrams per 10 kilograms of body weight and had been given into two doses per day, before morning and evening meals

non supplemented; supplemented

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 5 - 16 years old with diffusely hyper echogenic liver at ultrasonography were included in the study.

You may not qualify if:

• Patients with secondary causes of steatosis including total parenteral nutrition, drugs causing fatty liver disease for example steroids, hepatitis A, B, C, cytomegalovirus, Epstein-Barr virus infections, autoimmune liver disease, metabolic liver diseases, Wilson's disease, and alpha-1-antitrypsin deficiency.
• Patients currently taking fish oil supplements.
• Patients with systemic illness such as cardiac and kidney diseases.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Pediatrics hospital Ain shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Fatty Liver

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• zeinab Kabbany, professor

  Ain Shmas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pediatrics

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: March 1, 2019
• Primary Completion: January 25, 2020
• Study Completion: February 19, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)