Back to resultsOmega 3 Supplementation in Children With Non Alcoholic Fatty Liver (omega 3)
Primary Purpose
Fatty Liver
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
omega 3 fatty acids
Sponsored by
About this trial
This is an interventional treatment trial for Fatty Liver
Eligibility Criteria
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.
Sites / Locations
- Pediatrics hospital Ain shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
supplemented
non supplemented
Arm Description
Life style modification, diet regimen and Omega-3 fatty acids supplementation
Life style modification and diet regimen
Outcomes
Primary Outcome Measures
grade of fatty liver in children
improvement
Secondary Outcome Measures
Full Information
NCT ID
NCT04281121
First Posted
February 20, 2020
Last Updated
February 20, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04281121
Brief Title
Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver
Acronym
omega 3
Official Title
the Effect of Omega 3 Fatty Acids Supplements on Antioxidant Capacity in Egyptian Children With Non Alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 25, 2020 (Actual)
Study Completion Date
February 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supplemented
Arm Type
Active Comparator
Arm Description
Life style modification, diet regimen and Omega-3 fatty acids supplementation
Arm Title
non supplemented
Arm Type
Active Comparator
Arm Description
Life style modification and diet regimen
Intervention Type
Dietary Supplement
Intervention Name(s)
omega 3 fatty acids
Intervention Description
: 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
Primary Outcome Measure Information:
Title
grade of fatty liver in children
Description
improvement
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeinab Kabbany, professor
Organizational Affiliation
Ain Shmas University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatrics hospital Ain shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver
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