Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group

PHASE3CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Non Alcoholic Fatty Liver Disease
Interventions
DRUG

SAMe 1000 mg

1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner

DRUG

SAMe 1500 mg

1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner

DRUG

SAMe 2000 mg

2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner

Trial Locations (32)

30625

Site Reference ID 93917, Hanover

33604

Site Reference ID 93896, Pessac

34295

Site Reference ID 93913, Montpellier

49933

Site Reference ID 93895, Angers

53127

Site Reference ID 93953, Bonn

55131

Site Reference ID 93918, Mainz

60594

Site Reference ID 93954, Frankfurt

66424

Site Reference ID 93933, Homburg

75012

Site Reference ID 93915, Paris

75651

Site Reference ID 93893, Paris

79106

Site Reference ID 93935, Freiburg im Breisgau

80054

Site Reference ID 93914, Amiens

89081

Site Reference ID 94014, Ulm

93009

Site Reference ID 93894, Bobigny

119435

Site reference ID ORG-000906, Moscow

344022

Site reference ID ORG-000920, Rostov-on-Don

355017

Site reference ID ORG-000901, Stavropol

443011

Site reference ID ORG-000904, Samara

603126

Site reference ID ORG-000900, Nizhny Novgorod

630084

Site reference ID ORG-000907, Novosibirsk

644043

Site reference ID ORG-000903, Omsk

660022

Site reference ID ORG-000905, Krasnoyarsk

06202

Site Reference ID 93916, Nice

06120

Site Reference ID 93955, Halle

04103

Site Reference ID 94015, Leipzig

85-030

Site reference ID/Investigator # 109455, Bydgoszcz

41-500

Site Reference ID 93958, Chorzów

31-531

Site Reference ID 93973, Krakow

91-347

Site Reference ID 93956, Lodz

41-400

Site Reference ID 93957, Mysłowice

02-507

Site Reference ID 93974, Warsaw

50-220

Site Reference ID 93975, Wroclaw

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Abbott

INDUSTRY