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Dietary Supplement

DHA EE (1.89 g) and Vitamin E (1000 mg) for Non-alcoholic Fatty Liver Disease (PUVENAFLD Trial)

Phase 2
Waitlist Available
Led By Naga P. Chalasani, MD
Research Sponsored by Naga P. Chalasani
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 baseline to 6 months
Awards & highlights

PUVENAFLD Trial Summary

This trial is testing whether a combination of Vitamin E and Omega-3 fatty acids can reduce liver fat content in people with non-alcoholic fatty liver disease, a condition for which there is currently no approved drug treatment.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

PUVENAFLD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo
Secondary outcome measures
Change After 6 Months of DHA EE and /or Vitamin E Intervention in the Anthropometric Measure, Bodyweight.
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Body Mass Index (BMI)
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.
+20 more

PUVENAFLD Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: DHA EE (1.89 g) and Vitamin E (1000 mg)Active Control1 Intervention
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Group II: Vitamin E (1000 mg)Active Control1 Intervention
Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months.
Group III: DHA EE (1.89 g)Active Control1 Intervention
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Group IV: PlaceboPlacebo Group1 Intervention
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.

Find a Location

Who is running the clinical trial?

Naga P. ChalasaniLead Sponsor
1 Previous Clinical Trials
19 Total Patients Enrolled
DSM Nutritional Products, Inc.Industry Sponsor
93 Previous Clinical Trials
57,074 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
10 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Naga P. Chalasani, MD4.17 ReviewsPrincipal Investigator - Indiana University School of Medicine
Indiana University School of Medicine
5Patient Review
Although I love Dr Chalasani, I was scheduled with his p.a. more often than him. She was unfortunately not great. I had to correct her multiple times on things about my health record.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
Naga P. Chalasani 2020. "Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04198805.
~39 spots leftby Apr 2025
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