A Phase 3 interventional study of Docosahexaenoic Acid plus Vitamin E plus choline and placebo pearls 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 2016-01-14.
Sponsored by Bambino Gesù Hospital and Research Institute · Phase 3, Interventional, and Treatment
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline 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, VIT E and Choline (n=30)or an identical placebo (n=30) given orally for a period of 12 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 12-month study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonography of the liver will be repeated after six months 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 plus Vitamin E (39 UI) plus Choline 201 mg by mouth every day in association with lifestyle intervention \[hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity\] for 6 months
Drug: Docosahexaenoic Acid plus Vitamin E plus choline
placebo: this group will treated with identical placebo pearls given orally in association with lifestyle intervention \[hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity\] for 6 months
Drug: placebo pearls
DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg
placebo
Also known as: Placebo
Improvement in NAFLD Activity Score (NAS)
Time frame: 12 months
Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography
Time frame: 6 and 12 months
Safety
clinical examination, medical history and specific laboratory parameters
Time frame: 6 and 12 months
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Bambino Gesù Hospital and Research Institute