A randomized trial of iron depletion in patients with nonalcoholic fatty liver disease and hyperferritinemia

Table 1 Baseline features of 38 randomized subjects with nonalcoholic fatty liver disease and hyperferritinemia/increased iron stores according to treatment allocation

Baseline features	Lifestyle changes alone (n = 17)	Phlebotomy (n = 21)	P value
Age (yr)	53 ± 11	55 ± 8	0.45
Gender (female)	3 (18)	1 (5)	0.31
Waist circumference, cm	103 ± 11	102 ± 10	0.70
BMI (kg/m2)	28.2 ± 4.7	27.7 ± 3.5	0.71
HOMA-IR	4.1 ± 2.5	4.4 ± 2.3	0.67
HDL chol (mg/dL)	47 ± 18	48 ± 8	0.88
Triglycerides (mg/dL)	141 ± 87	129 ± 53	0.61
Type 2 diabetes	1 (6)	4 (19)	0.23
Ferritin (ng/mL)	642 (505-907)	710 (548-997)	0.40
TS (%)	40 ± 14	42 ± 13	0.67
HIC (μg/100 mg dry tissue)	234 (98-358)	303 (238-570)	0.23
TIS	6 (4-12)	9 (6-11)	0.19
ALT (UI/mL)	39 ± 29	43 ± 25	0.61
AST (UI/mL)	30 ± 14	31 ± 14	0.70
GGT (UI/mL)	40 (24-56)	28 (21-41)	0.36
US Steatosis grade > 1	17 (100)	17 (81)	0.11
NAS ≥ 3	11 (65)	13 (63)	1.00
Fibrosis stage 2-4	3 (18)	7 (33)	0.46
HFE genotype
C282Y+ or H63D +/+	2 (11)	2 (10)	0.82
Beta-thalassemia trait	4 (23)	4 (19)	1.00

Data are expressed as absolute numbers (percentage), mean ± SD or median (interquartile range). ALT: Alanine aminotransferases; AST: Aspartate aminotransferases; BMI: Body mass index; Chol: Cholesterol; GGT: Gamma-glutamyl-transferases; HDL: High density lipoprotein; HFE: Hemochromatosis gene; HIC: Hepatic iron concentration; HOMA-IR: Homeostasis model assessment insulin resistance index; NAS: Nonalcoholic fatty liver disease activity score; TIS: Tissue iron score; TS: Transferrin saturation; US: Ultrasonographic.

Table 2 Independent predictors of improvement of liver damage evaluated by multivariate logistic regression analysis at the end of the trial in 35 patients with nonalcoholic fatty liver disease and hyperferritinemia/increased iron stores (P < 0.0001 for model)

Independent predictors1	OR	95%CI	P value
Iron depletion by phlebotomy	265	8.9-1 × 106	0.0001
AST/ALT ratio	0.86	0.72-0.94	< 0.0001
HOMA-IR index	0.28	0.05-0.65	0.0003

¹Liver damage included direct or indirect evaluation of liver damage in all patients that completed follow-up. AST/ALT: Alanine aminotransferases/aspartate aminotransferases; HOMA-IR: Homeostasis model assessment insulin resistance index.