Fatty LiverPhase 1/2EDACNNCT00885313
Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)
A Phase 1/2 study testing DHA250, DHA500 and Lifestyle intervention in people with Fatty Liver and Liver Fibrosis, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Fatty Liver, Liver Fibrosis, Obesity
- What is being tested?
- DHA250, DHA500 and Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Mar 2011
- Phase
- Phase 1/2
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- persistently elevated serum aminotransferase levels
- diffusely echogenic liver on imaging studies suggestive of fatty liver
- biopsy consistent with the diagnosis of NAFLD
Who cannot join
- hepatic virus infections (HCV RNA-PCR negative)
- Hepatitis A, B, C, D, E and G
- cytomegalovirus and Epstein-Barr virus
- alcohol consumption
- history of parenteral nutrition
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
Read the detailed description
Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA 250 mg/kg/d (n=20), DHA 500 mg/kg/d (n=20), or an identical placebo (n=20) given orally for a period of 24 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.
Patients will undergo a medical evaluation every three months during the 24-month study period. Liver biopsy will be performed only at baseline and at the end of treatment. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. Ultrasonography and Fibroscan of the liver will be repeated at the end of the study period.
- Conditions
- Fatty Liver, Liver Fibrosis, Obesity, Metabolic Syndrome, Nonalcoholic Fatty Liver Disease
- Being tested
- DHA250, DHA500, PLACEBO, Lifestyle intervention
- Keywords
- NAFLD, NASH, fibrosis
- Medical subject headings
- Fatty Liver, Liver Cirrhosis, Obesity, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA250Drug
Also called Docosahexaenoic Acid
DHA 250 mg/kg/d
DHA500Drug
Also called Docosahexaenoic Acid
DHA 500 mg/kg/d
PLACEBODrug
Also called No interventions
placebo
Lifestyle interventionBehavioural
Also called Diet and physical activity
lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| DHA250 | Experimental | DHA 250 mg/kg/d plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity]. Receives: Drug: DHA250; Behavioral: Lifestyle intervention |
| DHA500 | Experimental | DHA 250 mg/kg/d plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity]. Receives: Drug: DHA500; Behavioral: Lifestyle intervention |
| PLA | Placebo comparator | placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity]. Receives: Drug: PLACEBO; Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver status by liver biopsy (steatosis and fibrosis)
Measured: months 24
Secondary outcomes (2)
Serum alanine transferase levels
Measured: month 24
Serum levels of triglycerides
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Valerio Nobili, MD, Principal investigator, Bambino Gesù Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885313
- Sponsor's protocol ID
- 1406-18-4
- Acronym
- EDACN
- Status last verified
- May 2011
- First submitted
- 20 Apr 2009
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nobili V, Bedogni G, Donati B, Alisi A, Valenti L. The I148M variant of PNPLA3 reduces the response to docosahexaenoic acid in children with non-alcoholic fatty liver disease. J Med Food. 2013 Oct;16(10):957-60. doi: 10.1089/jmf.2013.0043. Epub 2013 Sep 28.
PubMed 24074360Nobili V, Alisi A, Della Corte C, Rise P, Galli C, Agostoni C, Bedogni G. Docosahexaenoic acid for the treatment of fatty liver: randomised controlled trial in children. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1066-70. doi: 10.1016/j.numecd.2012.10.010. Epub 2012 Dec 7.
PubMed 23220074Nobili V, Bedogni G, Alisi A, Pietrobattista A, Rise P, Galli C, Agostoni C. Docosahexaenoic acid supplementation decreases liver fat content in children with non-alcoholic fatty liver disease: double-blind randomised controlled clinical trial. Arch Dis Child. 2011 Apr;96(4):350-3. doi: 10.1136/adc.2010.192401. Epub 2011 Jan 12.
PubMed 21233083
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).
- ClinicalTrials.gov ID
- NCT00885313
- Acronym / sponsor ID
- EDACN / 1406-18-4
- Conditions
- Fatty Liver, Liver Fibrosis, Obesity, Metabolic Syndrome, Nonalcoholic Fatty Liver Disease
- Keywords
- NAFLD, NASH, fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Apr 2009 (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 purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
Detailed description
Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA 250 mg/kg/d (n=20), DHA 500 mg/kg/d (n=20), or an identical placebo (n=20) given orally for a period of 24 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.
Patients will undergo a medical evaluation every three months during the 24-month study period. Liver biopsy will be performed only at baseline and at the end of treatment. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. Ultrasonography and Fibroscan of the liver will be repeated at the end of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DHA250 | Experimental | Drug: DHA250, Behavioral: Lifestyle interventionDHA 250 mg/kg/d plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity]. |
| DHA500 | Experimental | Drug: DHA500, Behavioral: Lifestyle interventionDHA 250 mg/kg/d plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity]. |
| PLA | Placebo comparator | Drug: PLACEBO, Behavioral: Lifestyle interventionplacebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity]. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- persistently elevated serum aminotransferase levels
- diffusely echogenic liver on imaging studies suggestive of fatty liver
- biopsy consistent with the diagnosis of NAFLD
Key exclusion criteria (7 listed)
- hepatic virus infections (HCV RNA-PCR negative)
- Hepatitis A, B, C, D, E and G
- cytomegalovirus and Epstein-Barr virus
- alcohol consumption
- history of parenteral nutrition
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 |
|---|---|---|
| DHA250Also: Docosahexaenoic AcidDHA 250 mg/kg/d | Drug | DHA250 |
| DHA500Also: Docosahexaenoic AcidDHA 500 mg/kg/d | Drug | DHA500 |
| PLACEBOAlso: No interventionsplacebo | Drug | PLA |
| Lifestyle interventionAlso: Diet and physical activitylifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months. | Behavioural | DHA250, DHA500, PLA |
Primary outcome
Liver status by liver biopsy (steatosis and fibrosis)
Time frame: months 24
2 secondary outcomes
Serum alanine transferase levels
Time frame: month 24
Serum levels of triglycerides
Time frame: 24 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 13 May 2011.
- Derived from this study: PubMed 24074360Nobili V, Bedogni G, Donati B, Alisi A, Valenti L. The I148M variant of PNPLA3 reduces the response to docosahexaenoic acid in children with non-alcoholic fatty liver disease. J Med Food. 2013 Oct;16(10):957-60. doi: 10.1089/jmf.2013.0043. Epub 2013 Sep 28.
- Derived from this study: PubMed 23220074Nobili V, Alisi A, Della Corte C, Rise P, Galli C, Agostoni C, Bedogni G. Docosahexaenoic acid for the treatment of fatty liver: randomised controlled trial in children. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1066-70. doi: 10.1016/j.numecd.2012.10.010. Epub 2012 Dec 7.
- Derived from this study: PubMed 21233083Nobili V, Bedogni G, Alisi A, Pietrobattista A, Rise P, Galli C, Agostoni C. Docosahexaenoic acid supplementation decreases liver fat content in children with non-alcoholic fatty liver disease: double-blind randomised controlled clinical trial. Arch Dis Child. 2011 Apr;96(4):350-3. doi: 10.1136/adc.2010.192401. Epub 2011 Jan 12.
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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.
Valerio Nobili, MD principal investigator
Bambino Gesù Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DHA250, DHA500 and Lifestyle intervention in people with Fatty Liver and Liver Fibrosis, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 3 inclusion and 7 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 13 May 2011. 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 Italy. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Liver status by liver biopsy (steatosis and fibrosis) (time frame: months 24). 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 NCT00885313, which also lists 3 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 13 May 2011.