Table 1.

Clinical trials assessing the impact of ω3 PUFA on Children with NAFLD¹.

Study (Ref)[Year]	ClinicalTrials.gov	Population	Treatment	Treatment	Key Outcomes
	NCT#	Baseline Values Patients/group	ω3 PUFA (Dose, mg/d;	Duration (Months)	ω3 PUFA vs Placebo
Nobili et al [2011]	885313	Age: <18 yrs 20 per group ALT> 40 U/L Biopsy Proven NAFLD	Placebo vs DHA 250 & 500 mg/d	6	Plasma ALT ↓ Insulin Sensitivity ↑ Blood DHA↑ Hepatosteatosis [US]1 ↓
Nobili et al [2013]	885313	Age: <18 yrs 8M/12F per group ALT≥57 U/L	Placebo vs DHA 250 & 500 mg/d	6, 12, 18, 24	Plasma ALT ↓ Blood DHA ↑ Hepatosteatosis [US] ↓
Nobili et al [2014]	885313	Age: <18 yrs Mean Age, 12 8M/12F per group ALT>57 U/L	Placebo vs DHA 250 & 500 mg/d	6, 12, 18, 24	Serum Cytokines ↓ Blood DHA ↑ NAS ↓ Hepatic GPR120 mRNA ↑ NFκB-pSer311 ↓
Janczyk, et al [2015]	1547910	Age: >5, <19 yrs Placebo group = 30 ω3 PUFA group = 34 ALT ≥54 U/L	Placebo vs EPA + DHA 450–1300 mg/d Weight Adjusted	3, 6	Blood ω3 PUFA [NR] Plasma Triglycerides, [NC] Plasma Adiponectin↑; AST ↓ Hepatosteatosis [US]; [NC]
Pacifico, et al [2015]		Placebo: Mean Age: 11 16 Males ω3 PUFA: Mean Age: 11 14 males	Placebo vs 250 mg oil/d 39% DHA	6	Body weight ↓; Waist circum. ↓ Plasma ALT [NC]; Insulin ↓ Plasma Triglycerides, ↓ Blood DHA, ↑ Hepatosteatosis [H], ↓
Boyraz, et al [2015]		Placebo: Mean age = 13.8 yrs 27M; 29F ALT, > 56U/L ω3 PUFA Mean Age, 13.3 yrs 28 M; 24F ALT, >58 U/L	Placebo vs ω3 PUFA Marincap, 1 g/d [FA-EE 18% EPA 12% DHA]	12	Plasma ALT ↓; AST ↓ Fasting Insulin ↓; HOMA-IR ↓ Plasma Triglycerides, ↓ Blood ω3 PUFA [NR] Hepatosteatosis [US] ↓

Abbreviations: NAS, NASH activity score; H, Histology; US, hepatic ultrasound; NR, not reported; NC, no change; FA-EE, fatty acid ethyl esters.