Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Brief Summary: Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resistance. Therapy usually includes recommendations to increase exercise and to begin weight reducing diets but these goals are variably achieved and their relative effects in conjunction with pharmacological intervention have not been well defined. Moreover, these lifestyle changes can confound results of treatment trials if not quantified through conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially formulation rich in omega-3, are widely accepted and endorsed in the medical community for their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3 fatty acid (3gm/day) will produce improvement in NASH histological injury independent of changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The effects of the supplement will be compared to a placebo group and controlled for these lifestyle changes.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: n-3 PUFA | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Rosuvastatin | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: n-3 PUFA; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Rosuvastatin; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
B: Arm Label: Omega 3 recipient arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Omega 3 Fish Oil supplements | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Omega 3 Fish Oil supplements; Assigned to Arm(s): Omega 3 recipient arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Vitamin D + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: vitamin D3, Drug: omega-3 fatty acids (fish oil) | Arm Label: Vitamin D + fish oil placebo; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: vitamin D3, Dietary Supplement: Fish oil placebo | Arm Label: Vitamin D placebo + fish oil; Type: ACTIVE_COMPARATOR; Interventions: Drug: omega-3 fatty acids (fish oil), Dietary Supplement: Vitamin D3 placebo | Arm Label: Vitamin D placebo + fish oil placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: Fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: vitamin D3; Assigned to Arm(s): Vitamin D + fish oil, Vitamin D + fish oil placebo | Intervention Type: DRUG; Name: omega-3 fatty acids (fish oil); Assigned to Arm(s): Vitamin D + fish oil, Vitamin D placebo + fish oil | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3 placebo; Assigned to Arm(s): Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Fish oil placebo; Assigned to Arm(s): Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo
D: Arm Label: Safflower oil; Type: EXPERIMENTAL; Interventions: Other: Safflower oil | Arm Label: Control group (no diet instruction); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Safflower oil; Assigned to Arm(s): Safflower oil

Answer: B