Effect of Vitamin E on Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)

NCT00655018 | Completed Phase 2 DMC

• 1 other identifier: VITENAFLD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and adolescents. We aim to determine the efficacy of lifestyle intervention with or without antioxidant therapy in pediatric NAFLD.

Conditions

Inflammation; Fibrosis; Insulin Resistance

Keywords

Non-Alcoholic Fatty Liver Disease (NAFLD); Non-Alcoholic Steatohepatitis (NASH); Liver histology; Insulin Resistance; Weight loss; Alpha-tocopherol; ascorbic acid

Outcome Measures

Primary Outcomes (1)

• serum levels of aminotransferases

  months 12 and 24

Secondary Outcomes (1)

• Liver histology (inflammation and fibrosis)

  month 24

Study Arms (2)

Vitamin group

EXPERIMENTAL

alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

Dietary Supplement: Vitamin treatment (alpha tocopherol plus ascorbic acid)

2

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin treatment (alpha tocopherol plus ascorbic acid) DIETARY_SUPPLEMENT

alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

Also known as: alpha-tocoferol

Vitamin group

Placebo DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• persistently elevated serum aminotransferase levels,
• diffusely echogenic liver on imaging studies suggestive of fatty liver, and
• 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,
• and use of drugs known to induce steatosis (e.g. valproate, amiodarone or prednisone) 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)

Dept. Of HepatoGastoEnterology and Nutrition, Liver Unit

Rome, 00165, Italy

Location

Related Publications (4)

• Bugianesi E, Gentilcore E, Manini R, Natale S, Vanni E, Villanova N, David E, Rizzetto M, Marchesini G. A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease. Am J Gastroenterol. 2005 May;100(5):1082-90. doi: 10.1111/j.1572-0241.2005.41583.x.

  PMID: 15842582 BACKGROUND

• Vajro P, Mandato C, Franzese A, Ciccimarra E, Lucariello S, Savoia M, Capuano G, Migliaro F. Vitamin E treatment in pediatric obesity-related liver disease: a randomized study. J Pediatr Gastroenterol Nutr. 2004 Jan;38(1):48-55. doi: 10.1097/00005176-200401000-00012.

  PMID: 14676594 BACKGROUND

• Lavine JE. Vitamin E treatment of nonalcoholic steatohepatitis in children: a pilot study. J Pediatr. 2000 Jun;136(6):734-8.

  PMID: 10839868 BACKGROUND

• Nobili V, Manco M, Devito R, Ciampalini P, Piemonte F, Marcellini M. Effect of vitamin E on aminotransferase levels and insulin resistance in children with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1553-61. doi: 10.1111/j.1365-2036.2006.03161.x.

  PMID: 17206944 RESULT

Related Links

• Hospital's web site

MeSH Terms

Conditions

Inflammation; Fibrosis; Insulin Resistance; Non-alcoholic Fatty Liver Disease; Weight Loss

Interventions

alpha-Tocopherol; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tocopherols; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Valerio Nobili, MD

  Bambino Gesù Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: January 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: April 9, 2008

Record last verified: 2008-03

Locations

IT (1)