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

NCT00885313 | Completed Phase 1 DMC

• 1 other identifier: 1406-18-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease

Keywords

NAFLD; NASH; fibrosis

Outcome Measures

Primary Outcomes (1)

• Liver status by liver biopsy (steatosis and fibrosis)

  months 24

Secondary Outcomes (2)

• Serum alanine transferase levels

  month 24

• Serum levels of triglycerides

  24 months

Study Arms (3)

DHA250

EXPERIMENTAL

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

Drug: DHA250; Behavioral: Lifestyle intervention

DHA500

EXPERIMENTAL

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

Drug: DHA500; Behavioral: Lifestyle intervention

PLA

PLACEBO COMPARATOR

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

Drug: PLACEBO; Behavioral: Lifestyle intervention

Interventions

DHA250 DRUG

DHA 250 mg/kg/d

Also known as: Docosahexaenoic Acid

DHA250

DHA500 DRUG

DHA 500 mg/kg/d

Also known as: Docosahexaenoic Acid

DHA500

PLACEBO DRUG

placebo

Also known as: No interventions

PLA

Lifestyle intervention 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.

Also known as: Diet and physical activity

DHA250; DHA500; PLA

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Rome, Rome, 00165, Italy

Location

Related Publications (3)

• 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.

  PMID: 24074360 DERIVED

• 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.

  PMID: 23220074 DERIVED

• 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.

  PMID: 21233083 DERIVED

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis; Obesity; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Fibrosis

Interventions

Docosahexaenoic Acids; Diet; Exercise

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Valerio Nobili, MD

  Bambino Gesù Children Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

IT (1)