Non-alcoholic Fatty Liver DiseasePhase 2NCT01547910
Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
A Phase 2 study testing Fish Oil in people with Non-alcoholic Fatty Liver Disease, run by Piotr Socha.
Trial summary
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 6 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Apr 2012
- Phase
- Phase 2
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 6-19
- overweight or obesity
- ALT activity over 130% of upper limit norm
- hyperechogenicity of the liver on ultrasound
Who cannot join
- HCV, HBV infection
- cholestasis
- chronic/acute liver failure
- alpha-1-antitrypsin deficiency
- Wilson disease
- type 2 diabetes mellitus
Show all 10Show fewer
- beta-oxidation defects
- alcohol consumption
- history of parenteral nutrition
- use of drugs
About this study
Official title: Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
Read the detailed description
76 children or adolescents aged 6-19 with NAFLD will be included in the study. Diagnosis of NAFLD is set by increased alanine transaminase and features of liver steatosis on ultrasound. Patients will be randomized to receive either fish oil (EPA/DHA, 400-1200mg) or placebo (sunflower oil) for 6 months. All children will be advised to reduce weight (dietetic intervention + increased physical activity). Laboratory tests, liver ultrasound, anthropometric analysis will be performed at the start, after 3 months and 6 months.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Fish Oil
- Keywords
- fatty liver, hepatitis, insulin resistance, unsaturated fatty acids, NAFLD, children
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Hepatitis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Fish oil given in supplementary dose
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | Children will receive fish oil capsules according to age as described in the protocol Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum alanine transaminase level decrease min. 0.3 upper limit of normal
Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
Measured: 6 months
Secondary outcomes (5)
normalization of liver imaging on ultrasound
'Fish oil' group will be compared to 'placebo' group
Measured: after 6 months of therapy
ALT and AST activity
'Fish oil' group will be compared to 'placebo' group
Measured: 6 months
Insulin resistance markers as Homa-IR
'Fish oil' group will be compared to 'placebo' group
Measured: 6 months
Fat and lean body mass measurements
'Fish oil' group will be compared to 'placebo' group
Measured: 6 months
Caloric intake including fat intake and sucrose intake
'Fish oil' group will be compared to 'placebo' group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startAug 2007
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piotr Socha
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Bialystok, Medical University of Silesia, Pediatric Municipal Hospital of Rzeszow, Poland
- Responsible party
- Sponsor-investigator, Piotr Socha, Children's Memorial Health Institute, Poland
- Investigators
- Piotr Socha, Principal investigator, Children's Memorial Health Institute, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547910
- Sponsor's protocol ID
- ChildrensMHIPoland
- Status last verified
- Aug 2014
- First submitted
- 29 Feb 2012
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janczyk W, Lebensztejn D, Wierzbicka-Rucinska A, Mazur A, Neuhoff-Murawska J, Matusik P, Socha P. Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease: a randomized controlled trial. J Pediatr. 2015 Jun;166(6):1358-63.e1-3. doi: 10.1016/j.jpeds.2015.01.056. Epub 2015 Mar 11.
PubMed 25771388Janczyk W, Socha P, Lebensztejn D, Wierzbicka A, Mazur A, Neuhoff-Murawska J, Matusik P. Omega-3 fatty acids for treatment of non-alcoholic fatty liver disease: design and rationale of randomized controlled trial. BMC Pediatr. 2013 May 23;13:85. doi: 10.1186/1471-2431-13-85.
PubMed 23702094
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT01547910
- Acronym / sponsor ID
- ChildrensMHIPoland
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- fatty liver, hepatitis, insulin resistance, unsaturated fatty acids, NAFLD, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Piotr SochaUniversity, hospital or other
- Collaborators
- Medical University of Bialystok, Medical University of Silesia, Pediatric Municipal Hospital of Rzeszow, Poland
- Study start
- Aug 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Mar 2012 (estimated)
- 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.
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
Detailed description
76 children or adolescents aged 6-19 with NAFLD will be included in the study. Diagnosis of NAFLD is set by increased alanine transaminase and features of liver steatosis on ultrasound. Patients will be randomized to receive either fish oil (EPA/DHA, 400-1200mg) or placebo (sunflower oil) for 6 months. All children will be advised to reduce weight (dietetic intervention + increased physical activity). Laboratory tests, liver ultrasound, anthropometric analysis will be performed at the start, after 3 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Dietary Supplement: Fish OilChildren will receive fish oil capsules according to age as described in the protocol |
| Placebo | Placebo comparator | Dietary Supplement: Fish OilSunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age 6-19
- overweight or obesity
- ALT activity over 130% of upper limit norm
- hyperechogenicity of the liver on ultrasound
Key exclusion criteria (10 listed)
- HCV, HBV infection
- cholestasis
- chronic/acute liver failure
- alpha-1-antitrypsin deficiency
- Wilson disease
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 |
|---|---|---|
| Fish OilFish oil given in supplementary dose | Dietary supplement | Fish oil, Placebo |
Primary outcome
Serum alanine transaminase level decrease min. 0.3 upper limit of normal
Time frame: 6 months
Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
5 secondary outcomes
normalization of liver imaging on ultrasound
Time frame: after 6 months of therapy
ALT and AST activity
Time frame: 6 months
Insulin resistance markers as Homa-IR
Time frame: 6 months
Fat and lean body mass measurements
Time frame: 6 months
Caloric intake including fat intake and sucrose intake
Time frame: 6 months
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 21 Aug 2014.
- Derived from this study: PubMed 25771388Janczyk W, Lebensztejn D, Wierzbicka-Rucinska A, Mazur A, Neuhoff-Murawska J, Matusik P, Socha P. Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease: a randomized controlled trial. J Pediatr. 2015 Jun;166(6):1358-63.e1-3. doi: 10.1016/j.jpeds.2015.01.056. Epub 2015 Mar 11.
- Derived from this study: PubMed 23702094Janczyk W, Socha P, Lebensztejn D, Wierzbicka A, Mazur A, Neuhoff-Murawska J, Matusik P. Omega-3 fatty acids for treatment of non-alcoholic fatty liver disease: design and rationale of randomized controlled trial. BMC Pediatr. 2013 May 23;13:85. doi: 10.1186/1471-2431-13-85.
Related trials for Non-alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
Piotr Socha principal investigator
Children's Memorial Health Institute, Warsaw, Poland
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish Oil in people with Non-alcoholic Fatty Liver Disease, run by Piotr Socha.
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 4 inclusion and 10 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 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum alanine transaminase level decrease min. 0.3 upper limit of normal (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547910, which also lists 2 linked publications.
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 21 Aug 2014.