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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

NCT01754714 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2016-02-19

Study results available
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Summary

Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group

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

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Suntje Sander-Struckmeier, PhD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • France
  • Germany
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01754714 on ClinicalTrials.gov