A Phase 1/2 interventional study of DHA250 and DHA500 in Fatty Liver, Liver Fibrosis and Obesity, sponsored by Bambino Gesù Hospital and Research Institute. Completed at 1 site in Italy. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2011-05-13.
Sponsored by Bambino Gesù Hospital and Research Institute · Phase 1/2, Interventional, and Treatment
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).
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Bambino Gesù Hospital and Research Institute is the lead sponsor of 53 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
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
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
DHA 250 mg/kg/d
Also known as: Docosahexaenoic Acid
DHA 500 mg/kg/d
Also known as: Docosahexaenoic Acid
placebo
Also known as: No interventions
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
Liver status by liver biopsy (steatosis and fibrosis)
Time frame: months 24
Serum alanine transferase levels
Time frame: month 24
Serum levels of triglycerides
Time frame: 24 months
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Bambino Gesù Hospital and Research Institute