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Sponsored by: |
Bambino Gesù Hospital and Research Institute |
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Information provided by: | Bambino Gesù Hospital and Research Institute |
ClinicalTrials.gov Identifier: | NCT00655018 |
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.
Condition | Intervention | Phase |
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Inflammation Fibrosis Insulin Resistance |
Dietary Supplement: Vitamin treatment (alpha tocopherol plus ascorbic acid) Dietary Supplement: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Lifestyle Intervention and Antioxidants in Children With Nonalcoholic Fatty Liver Disease: A Randomized, Controlled Trial |
Enrollment: | 90 |
Study Start Date: | January 2003 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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].
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Dietary Supplement: 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].
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2: Placebo Comparator
placebo and lifestyle intervention [hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
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Dietary Supplement: Placebo
placebo and lifestyle intervention [hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
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InChildren or adolescents with well-characterized and liver biopsy confirmed NAFLD will be enrolled. They will be randomized to treatment with alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d (n=45) or an identical placebo (n=45) given orally. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise. The body mass index (BMI) and BMI Z-score will be calculated . Obesity was defined for a percentile of BMI ≥ 95th percentile for age and gender .
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.
Ages Eligible for Study: | 3 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Dept. Of HepatoGastoEnterology and Nutrition, Liver Unit | |
Rome, Italy, 00165 |
Principal Investigator: | Valerio Nobili, MD | Bambino Gesù Hospital and Research Institute |
Responsible Party: | Bambino Gesù Hospital and Research Institute ( Valerio Nobili, MD ) |
Study ID Numbers: | VITENAFLD |
Study First Received: | April 3, 2008 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00655018 History of Changes |
Health Authority: | Italy: Ethics Committee |
Non-Alcoholic Fatty Liver Disease (NAFLD) Non-Alcoholic Steatohepatitis (NASH) Liver histology Insulin Resistance |
Weight loss Alpha-tocopherol ascorbic acid |
Liver Diseases Antioxidants Fibrosis Tocopherol Fatty Liver Insulin Body Weight Tocopherols Hyperinsulinism Tocotrienol Vitamins Weight Loss Tocotrienols Micronutrients |
Metabolic Disorder Tocopherol acetate Non-alcoholic Steatohepatitis (NASH) Metabolic Diseases Trace Elements Inflammation Alpha-Tocopherol Vitamin C Vitamin E Digestive System Diseases Insulin Resistance Glucose Metabolism Disorders Ascorbic Acid |
Tocopherol acetate Liver Diseases Antioxidants Metabolic Diseases Molecular Mechanisms of Pharmacological Action Fibrosis Growth Substances Physiological Effects of Drugs Fatty Liver Protective Agents Pharmacologic Actions Inflammation |
Alpha-Tocopherol Tocopherols Hyperinsulinism Vitamin E Digestive System Diseases Pathologic Processes Vitamins Tocotrienols Micronutrients Insulin Resistance Glucose Metabolism Disorders Ascorbic Acid |