Omega-3 fatty acids for treatment of non-alcoholic fatty liver disease: design and rationale of randomized controlled trial

Table 2 Investigation schedule

Procedure	Inclusion	Treatment period		Follow-up
	M0	M1	M2	M3
	Week 0	Week 12	Week 24	Week 48
Written consent	X
Medical history	X	X	X	X
Randomization	X
Study drug dispensing	X	X
End of study drug treatment			X
Compliance		X	X	X
Adverse events monitoring		X	X	X
Previous and concomitant treatment	X	X	X	X
Vital signs and physical examination	X	X	X	X
Anthropometry + TANITA® bioimpedance	X	X	X	X
Abdominal utrasound	X		X	X
^a Liver biopsy	X
Dietary assessment:
- dietetic counseling	X	X	X	X
- 3 day food record	X
- FFQ	X		X
Physical activity:
- general counselling	X	X	X	X
- IPAQ	X		X
Laboratory tests:
- hematology	X		X
- ALT,AST, GGTP, bilirubin, INR	X	X	X	X
- fasting glucose, insulin	X	X	X	X
- OGTT glucose, insulin 0-240mins	X
- fasting lipids profile	X		X	X
- adipokines, cytokines, antioxidants	X		X
- fatty acid composition of plasma phospholipids	X		X
^a DEXA	X		X
^a MRI - body fat distribution	X		X
^a 1H-MRS - liver fat content	X		X

^aDone in selected patients.
Vital signs: mean BP, HR and temperature.
Anthropometry includes measurements of body weight and height, waist, hips and mid upper arm circumference (IOTF, WHO), triceps, abdominal and subscapular skin fold thickness.
OGTT glucose and insulin measurements were performed in intervals every 30 minutes from 0 to 240 minutes.

ISSN: 1471-2431