omega 3: Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04281121

Collaborator

(none)

Enrollment

Location

Arms

11.7

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver	Dietary Supplement: omega 3 fatty acids	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

the Effect of Omega 3 Fatty Acids Supplements on Antioxidant Capacity in Egyptian Children With Non Alcoholic Fatty Liver Disease

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Jan 25, 2020

Actual Study Completion Date :

Feb 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: supplemented Life style modification, diet regimen and Omega-3 fatty acids supplementation	Dietary Supplement: 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
Active Comparator: non supplemented Life style modification and diet regimen	Dietary Supplement: 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

Arm

Intervention/Treatment

Active Comparator: supplemented

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

Dietary Supplement: 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

Active Comparator: non supplemented

Life style modification and diet regimen

Dietary Supplement: omega 3 fatty acids

Outcome Measures

Primary Outcome Measures

grade of fatty liver in children [3 month]
improvement

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatrics hospital Ain shams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: zeinab Kabbany, professor, Ain Shmas University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yasmin gamal el gendy, professor of pediatrics, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04281121

Other Study ID Numbers:

MD 44/2017

First Posted:

Feb 24, 2020

Last Update Posted:

Feb 24, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Feb 24, 2020