Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD) (EDACN)

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ClinicalTrials.gov Identifier: NCT00885313

Recruitment Status : Completed

First Posted : April 21, 2009

Last Update Posted : May 13, 2011

Sponsor:

Information provided by:

Bambino Gesù Hospital and Research Institute

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Fatty Liver Liver Fibrosis Obesity Metabolic Syndrome Nonalcoholic Fatty Liver Disease	Drug: DHA250 Drug: DHA500 Drug: PLACEBO Behavioral: Lifestyle intervention	Phase 1 Phase 2

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


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).
Study Start Date :	March 2009
Actual Primary Completion Date :	April 2010
Actual Study Completion Date :	March 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Non-alcoholic fatty liver disease

MedlinePlus related topics: Fatty Liver Disease Liver Diseases

Drug Information available for: Doconexent

Genetic and Rare Diseases Information Center resources: Visceral Steatosis Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: DHA250 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].	Drug: DHA250 DHA 250 mg/kg/d Other Name: Docosahexaenoic Acid Behavioral: Lifestyle intervention lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months. Other Name: Diet and physical activity
Experimental: DHA500 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].	Drug: DHA500 DHA 500 mg/kg/d Other Name: Docosahexaenoic Acid Behavioral: Lifestyle intervention lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months. Other Name: Diet and physical activity
Placebo Comparator: PLA placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].	Drug: PLACEBO placebo Other Name: No interventions Behavioral: Lifestyle intervention lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months. Other Name: Diet and physical activity

Outcome Measures

Primary Outcome Measures :

Liver status by liver biopsy (steatosis and fibrosis) [ Time Frame: months 24 ]

Secondary Outcome Measures :

Serum alanine transferase levels [ Time Frame: month 24 ]
Serum levels of triglycerides [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	4 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

persistently elevated serum aminotransferase levels
diffusely echogenic liver on imaging studies suggestive of fatty liver
biopsy consistent with the diagnosis of NAFLD

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885313

Locations


Italy
Bambino Gesù Hospital and Research Institute
Rome, Italy, 00165

Sponsors and Collaborators

Bambino Gesù Hospital and Research Institute

Investigators


Principal Investigator:	Valerio Nobili, MD	Bambino Gesù Children Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Nobili V, Alisi A, Della Corte C, Risé 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.

Nobili V, Bedogni G, Alisi A, Pietrobattista A, Risé 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.


Responsible Party:	Valerio Nobili, MD, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:	NCT00885313 History of Changes
Other Study ID Numbers:	1406-18-4
First Posted:	April 21, 2009 Key Record Dates
Last Update Posted:	May 13, 2011
Last Verified:	May 2011

Keywords provided by Bambino Gesù Hospital and Research Institute:


NAFLD NASH fibrosis

Additional relevant MeSH terms:


Fatty Liver Non-alcoholic Fatty Liver Disease Fibrosis Metabolic Syndrome X Liver Diseases Liver Cirrhosis	Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Digestive System Diseases

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