Effect of Vitamin E on Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT00655018
Last Updated: 2008-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2003-01-31
2006-10-31
Brief Summary
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Detailed Description
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Patients will undergo a medical evaluation every three months during the 24-month study period. Laboratory tests including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. Ultrasonography of the liver will be repeated at the end of the study period.
Evaluation of Glucose Metabolism and Insulin Sensitivity A 2-hour oral glucose tolerance test (OGTT) will be performed at baseline and repeated at 24 mo. of treatment with the standard 1.75 g of glucose per kg, or maximum of 75 g. Glucose tolerance status will be determined according to the classification of the American Diabetes Association in which fasting plasma glucose (FPG) levels up to 99 mg/dl are considered normal; impaired fasting glucose (IFG) is defined by a FPG of 100-125 mg/dl; impaired glucose tolerance (IGT) is defined by a 2-hour plasma glucose of 140-199 mg/dl; diabetes mellitus is defined by a FPG ≥126 mg/dl, or a 2-hour plasma glucose ≥200 mg/dl .
The degrees of insulin resistance and sensitivity will be determined, respectively, by the homeostatic model assessment (HOMA-IR) using the formula: IR = (insulin\*glucose)/22.5; and by the insulin sensitivity index (ISI) derived from OGTT using the formula: ISI = (10,000/square root of \[fasting glucose x fasting insulin\] x \[mean glucose x mean insulin during OGTT\]).
Liver biopsy Liver biopsy will be performed at baseline and repeated at 24 mo. of treatment. Biopsies will be routinely processed and analyzed as described previously. Pre- and post-treatment liver biopsies will be reviewed and scored by a single pathologist who will be unaware of the assigned treatment, patients' clinical and laboratory data, and liver biopsy sequence. The main histological features of NAFLD including steatosis (macro and microvesicular), inflammation (portal and lobular), hepatocyte ballooning, and fibrosis will be scored using the scoring system for NAFLD recently proposed by the NIH-sponsored NASH Clinical Research Network.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin group
alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
Vitamin treatment (alpha tocopherol plus ascorbic acid)
alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
2
placebo and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
Placebo
placebo and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
Interventions
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Vitamin treatment (alpha tocopherol plus ascorbic acid)
alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
Placebo
placebo and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diffusely echogenic liver on imaging studies suggestive of fatty liver, and
* biopsy consistent with the diagnosis of NAFLD.
Exclusion Criteria
* 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.
3 Years
20 Years
ALL
No
Sponsors
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Bambino Gesù Hospital and Research Institute
OTHER
Responsible Party
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Bambino Gesù Hospital and Research Institute
Principal Investigators
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Valerio Nobili, MD
Role: PRINCIPAL_INVESTIGATOR
Bambino Gesù Hospital and Research Institute
Locations
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Dept. Of HepatoGastoEnterology and Nutrition, Liver Unit
Rome, , Italy
Countries
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References
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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.
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.
Lavine JE. Vitamin E treatment of nonalcoholic steatohepatitis in children: a pilot study. J Pediatr. 2000 Jun;136(6):734-8.
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.
Related Links
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Hospital's web site
Other Identifiers
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VITENAFLD
Identifier Type: -
Identifier Source: org_study_id