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Antioxidant

Group A for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Indiana University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at randomization visit (study day 1) and end of study visit (week 24)
Awards & highlights

Study Summary

This trial is testing whether Vitamin E can help people with HIV who also have a fatty liver by seeing if the underlying liver condition gets better, worse, or stays the same.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Human Immunodeficiency Virus Infection
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at randomization visit (study day 1) and end of study visit (week 24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at randomization visit (study day 1) and end of study visit (week 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction
Secondary outcome measures
Impact of Treatment on ALT as a Noninvasive Marker of Hepatic Inflammation
Impact of Treatment on AST as a Noninvasive Marker of Hepatic Inflammation
Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group AActive Control1 Intervention
Vitamin E 800 IU/daily for 24 weeks
Group II: Group BPlacebo Group1 Intervention
Matching placebo for 24 weeks

Find a Location

Who is running the clinical trial?

Indiana University School of MedicineLead Sponsor
185 Previous Clinical Trials
142,790 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this medical research project?

"According to clinicaltrials.gov, this study is currently recruiting patients for participation - the initial posting was on December 1st 2019 and has been refreshed as recently as January 25th 2022."

Answered by AI

What potential risks should be taken into account with Group A treatments?

"Data supporting the security of Group A has been collected, which was sufficient for it to receive a rating of 2. However, no prior clinical data is available proving its efficacy in treatment."

Answered by AI

What is the current participation size of this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting participants who are willing to be part of the study; having been published on December 1st 2019 and revised most recently on January 25th 2022. A total of 56 volunteers must be recruited for this trial from 2 locations."

Answered by AI

Does the age requirement for participation in this experiment exclude those under fifty?

"To qualify for this study, participants must be aged between 18 and 75. Separately, there are 133 trials available to minors under the age of 18 as well as 568 studies targeting elderly individuals over 65 years old."

Answered by AI

What criteria must be met in order to qualify for participation in this research?

"The target demographic for this trial includes 56 HIV-positive patients aged 18 - 75. To qualify, the individual must have a confirmed infection and be willing to cooperate with all aspects of the study."

Answered by AI

Could you elaborate on other investigations that Group A has participated in?

"Group A was initially studied in 2008 at the George E Wahlen VA Medical Center. Thus far, 325 trials have been finalized with 12 of them being actively conducted out of Indianapolis."

Answered by AI

What medical issues are often addressed with Group A treatments?

"Group A is capable of treating long-chain omega-3 fatty acid deficiencies, vitamin insufficiencies, and dietary inadequacies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vitamin E for NASH Treatment in HIV Infected Individuals
Samer Gawrieh 2019. "Vitamin E for NASH Treatment in HIV Infected Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03669133.
~1 spots leftby Apr 2025
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