Fatty Liveromega 3NCT04281121
Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver
A study testing omega 3 fatty acids in people with Fatty Liver, run by Ain Shams University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- omega 3 fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 19 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 5 - 16 years old with diffusely hyper echogenic liver at ultrasonography were included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Omega 3 Fatty Acids Supplements on Antioxidant Capacity in Egyptian Children With Non Alcoholic Fatty Liver Disease
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
- Being tested
- omega 3 fatty acids
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3 fatty acidsDietary 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
| Study group | Role | What they receive |
|---|---|---|
| supplemented | Active comparator | Life style modification, diet regimen and Omega-3 fatty acids supplementation Receives: Dietary Supplement: omega 3 fatty acids |
| non supplemented | Active comparator | Life style modification and diet regimen Receives: Dietary Supplement: omega 3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade of fatty liver in children
improvement
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Mar 2019
- Primary completion25 Jan 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasmin gamal el gendy, Ain Shams University
- Investigators
- zeinab Kabbany, professor, Principal investigator, Ain Shmas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281121
- Sponsor's protocol ID
- MD 44/2017
- Acronym
- omega 3
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Omega 3 Fatty Acids Supplements on Antioxidant Capacity in Egyptian Children With Non Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04281121
- Acronym / sponsor ID
- omega 3 / MD 44/2017
- Conditions
- Fatty Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supplemented | Active comparator | Dietary Supplement: omega 3 fatty acidsLife style modification, diet regimen and Omega-3 fatty acids supplementation |
| non supplemented | Active comparator | Dietary Supplement: omega 3 fatty acidsLife style modification and diet regimen |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 5 - 16 years old with diffusely hyper echogenic liver at ultrasonography were included in the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | non supplemented, supplemented |
Primary outcome
grade of fatty liver in children
Time frame: 3 month
improvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zeinab Kabbany, professor principal investigator
Ain Shmas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega 3 fatty acids in people with Fatty Liver, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade of fatty liver in children (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.