Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver

NCT ID: NCT04281121

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-02-19

Brief Summary

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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

Detailed Description

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Conditions

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Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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supplemented

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

Group Type ACTIVE_COMPARATOR

omega 3 fatty acids

Intervention Type 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

Life style modification and diet regimen

Group Type ACTIVE_COMPARATOR

omega 3 fatty acids

Intervention Type 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

Interventions

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omega 3 fatty acids

: 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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yasmin gamal el gendy

professor of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zeinab Kabbany, professor

Role: PRINCIPAL_INVESTIGATOR

Ain Shmas University

Locations

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Pediatrics hospital Ain shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD 44/2017

Identifier Type: -

Identifier Source: org_study_id

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