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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04281121
Other study ID # MD 44/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date February 19, 2020

Study information

Verified date February 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 19, 2020
Est. primary completion date January 25, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Pediatrics hospital Ain shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary grade of fatty liver in children improvement 3 month
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