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

NCT ID: NCT00885313

Last Updated: 2011-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-03-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DHA250

DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

Group Type: EXPERIMENTAL

DHA250

Intervention Type: DRUG

DHA 250 mg/kg/d

Lifestyle intervention

Intervention Type: BEHAVIORAL

lifestyle intervention \[including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity\], for 12 months.

DHA500

DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

Group Type: EXPERIMENTAL

DHA500

Intervention Type: DRUG

DHA 500 mg/kg/d

Lifestyle intervention

Intervention Type: BEHAVIORAL

lifestyle intervention \[including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity\], for 12 months.

PLA

placebo and lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

placebo

Lifestyle intervention

Intervention Type: BEHAVIORAL

lifestyle intervention \[including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity\], for 12 months.

Interventions

DHA250

DHA 250 mg/kg/d

Intervention Type: DRUG

DHA500

DHA 500 mg/kg/d

Intervention Type: DRUG

PLACEBO

placebo

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Docosahexaenoic Acid; Docosahexaenoic Acid; No interventions; Diet and physical activity

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Bambino Gesù Hospital and Research Institute

Principal Investigators

Valerio Nobili, MD

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Children Hospital

Locations

Bambino Gesù Hospital and Research Institute

Rome, Rome, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 24074360 (View on PubMed)

Nobili 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.

Reference Type: DERIVED

PMID: 23220074 (View on PubMed)

Nobili 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.

Reference Type: DERIVED

PMID: 21233083 (View on PubMed)

Other Identifiers

1406-18-4

Identifier Type: -

Identifier Source: org_study_id