Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Hydroxytyrosol and Vitamin E in the Treatment of Children With Biopsy-proven NASH
Brief Summary: Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression to non-alcoholic steatohepatitis (NASH).

Hydroxytyrosol is a simple phenolic compound naturally occurring in olive and olive oil with antioxidant properties. Some studies have demonstrated that hydroxytyrosol show several anti-inflammatory and anti-atherogenic activities, such as the inhibition of LDL oxidation and platelet aggregation.

Alpha tocopherol (Vitamin E) is the most studied anti-oxydant in pediatric NAFLD with conflicting results. It inhibits proinflammatory cytokine production and attenuates the release of profibrogenic agents and liver collagen.

The purpose of this interventional study is to evaluate the efficacy and tolerability of Hydroxytyrosol and Vitamin E in the treatment of children with biopsy-proven NASH.


Options:
A: Arm Label: TREATED GROUP; Type: EXPERIMENTAL; Interventions: Drug: Hydroxytyrosol plus Vitamin E | Arm Label: PLACEBO GROUP; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxytyrosol plus Vitamin E; Assigned to Arm(s): TREATED GROUP | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): PLACEBO GROUP
B: Arm Label: Control; Type: EXPERIMENTAL; Interventions: Behavioral: Unsupervised exercise training | Arm Label: lifestyle counseling and exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Supervised exercise training | Intervention Type: BEHAVIORAL; Name: Unsupervised exercise training; Assigned to Arm(s): Control | Intervention Type: BEHAVIORAL; Name: Supervised exercise training; Assigned to Arm(s): lifestyle counseling and exercise
C: Arm Label: Lepicol probiotic & prebiotic formula+simple lifestyle advice; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lepicol probiotic & prebiotic formula, Other: Simple lifestyle advice | Arm Label: Simple lifestyle advice alone; Type: PLACEBO_COMPARATOR; Interventions: Other: Simple lifestyle advice | Intervention Type: DRUG; Name: Lepicol probiotic & prebiotic formula; Assigned to Arm(s): Lepicol probiotic & prebiotic formula+simple lifestyle advice | Intervention Type: OTHER; Name: Simple lifestyle advice; Assigned to Arm(s): Lepicol probiotic & prebiotic formula+simple lifestyle advice, Simple lifestyle advice alone
D: Arm Label: Vit E 200 IU/d; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 200 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 400; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 400 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 800; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 800 IU/d, Behavioral: Diet and Exercise | Intervention Type: DRUG; Name: Vitamin E 200 IU/d; Assigned to Arm(s): Vit E 200 IU/d | Intervention Type: DRUG; Name: Vitamin E 400 IU/d; Assigned to Arm(s): Vitamin E 400 | Intervention Type: DRUG; Name: Vitamin E 800 IU/d; Assigned to Arm(s): Vitamin E 800 | Intervention Type: BEHAVIORAL; Name: Diet and Exercise; Assigned to Arm(s): Vit E 200 IU/d, Vitamin E 400, Vitamin E 800

Answer: A