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Betaine in Patients With Nonalcoholic Steatohepatitis

NCT00586911 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-04-08

No results posted yet for this study

Summary

To assess the safety and efficacy of betaine in patients with NASH on markers of disease severity such as liver histology, liver biochemistries, and health related quality of life.

Conditions

Interventions

DRUG

Cystadane

Betaine 20 mg a day or identical placebo for 1 year.

DRUG

Identical Placebo

Placebo

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • Orphan Medical

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Keith D Lindor, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT00586911 on ClinicalTrials.gov