Trial · NCT04198805

Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)

NCT04198805, Phase 2, Completed, Naga P. Chalasani; results first posted 2023-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD). Trials, record NCT04198805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04198805

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
NCT number: NCT04198805
Status: Completed
Phases: Phase 2
Enrollment: 205 participants, actual
Lead sponsor: Naga P. Chalasani
Conditions: Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver, Non-Alcoholic Steatohepatitis
Interventions: Vitamin E [(all-rac)-α-tocopheryl acetate], Omega-3 fatty acid (DHA EE), Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate], Placebo
First posted: 2019-12-13
Last updated: 2023-05-25
Results first posted: 2023-05-25

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo	Baseline to 6 months	A change in liver fat content relative to baseline between Vitamin E and DHA EE vs placebo. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline).
Secondary	Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm	Baseline to 6 months	Change in liver fat content relative to baseline between Vitamin E vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline).
Secondary	Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm	Baseline to 6 months	Change in liver fat content relative to baseline between DHA EE vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline).
Secondary	Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.	Baseline to 6 months	Evaluation of baseline and 6 month measurements of waist circumference in the DHA EE and /or Vitamin E intervention over a 6 month period.
Secondary	Change After 6 Months of DHA EE and /or Vitamin E Intervention in the Anthropometric Measure, Bodyweight.	Baseline to 6 months	Evaluation of baseline and 6-month measurements of body weight in the DHA EE and /or Vitamin E intervention over a 6 month period.
Secondary	Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist-to-hip Ratio .	Baseline to 6 months	Evaluation of baseline and 6-month measurements of waist-to-hip ratio (the circumference of the waist divided by the circumference of the hips) in the DHA EE and /or Vitamin E intervention over a 6 month period.
Secondary	Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Body Mass Index (BMI)	Baseline to 6 months	Evaluation of baseline and 6-month measurements of body mass index (BMI) in the DHA EE and /or Vitamin E intervention over a 6 month period.
Secondary	Change in Insulin Levels to Determine Insulin Resistance	Baseline to 6 months
Secondary	Change in Liver Enzymes (ALT) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.	Baseline to 6 months	Evaluation of baseline and 6-month liver enzymes: alanine transaminase (ALT) in the DHA EE and /or Vitamin E intervention over a 6 month period value at (6 months minus value at baseline).
Secondary	Change in Liver Enzymes (AST) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.	Baseline to 6 months	Evaluation of baseline and 6-month liver enzymes: aspartate aminotransferase (AST) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).

1 to 10 of 24Source ClinicalTrials.gov

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Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	Percentage of liver fat	MEAN
SECONDARY	Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	Percentage of liver fat	MEAN
SECONDARY	Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	Percentage of liver fat	MEAN
SECONDARY	Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	centimeters (cm)	MEAN
SECONDARY	Change After 6 Months of DHA EE and /or Vitamin E Intervention in the Anthropometric Measure, Bodyweight.	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	kilogram (kg)	MEAN
SECONDARY	Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist-to-hip Ratio .	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	ratio	MEAN
SECONDARY	Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Body Mass Index (BMI)	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	kg/m^2	MEAN
SECONDARY	Change in Insulin Levels to Determine Insulin Resistance	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	ulU/mL	MEAN
SECONDARY	Change in Liver Enzymes (ALT) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	U/L	MEAN
SECONDARY	Change in Liver Enzymes (AST) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.	Baseline to 6 months	Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints	U/L	MEAN

1 to 10 of 24Source ClinicalTrials.gov

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Results by group122

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo	DHA EE (1.89 g) and Vitamin E (1000 mg)	-6.8	Standard Deviation 26.4	Percentage of liver fat
Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo	Placebo	-8.2	Standard Deviation 18.2	Percentage of liver fat
Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm	Vitamin E (1000 mg)	-10.4	Standard Deviation 15.7	Percentage of liver fat
Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm	Placebo	-8.2	Standard Deviation 18.2	Percentage of liver fat
Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm	DHA EE (1.89 g)	2.2	Standard Deviation 24.1	Percentage of liver fat
Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm	Placebo	-8.2	Standard Deviation 18.2	Percentage of liver fat
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.	DHA EE (1.89 g) and Vitamin E (1000 mg)	0.8	Standard Deviation 6.5	centimeters (cm)
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.	Vitamin E (1000 mg)	-0.5	Standard Deviation 4.9	centimeters (cm)
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.	DHA EE (1.89 g)	-0.2	Standard Deviation 6.0	centimeters (cm)
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.	Placebo	0.8	Standard Deviation 4.3	centimeters (cm)

1 to 10 of 122Source ClinicalTrials.gov

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Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vitamin E (1000 mg)	34
Overall Study	STARTED	DHA EE (1.89 g)	34
Overall Study	STARTED	DHA EE (1.89 g) and Vitamin E (1000 mg)	67
Overall Study	STARTED	Placebo	70
Overall Study	COMPLETED	Vitamin E (1000 mg)	26
Overall Study	COMPLETED	DHA EE (1.89 g)	30
Overall Study	COMPLETED	DHA EE (1.89 g) and Vitamin E (1000 mg)	61
Overall Study	COMPLETED	Placebo	60
Overall Study	NOT COMPLETED	Vitamin E (1000 mg)	8
Overall Study	NOT COMPLETED	DHA EE (1.89 g)	4

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events336

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anxiety	Nervous system disorders	Vitamin E (1000 mg)	0	34	0
other	Anxiety	Nervous system disorders	DHA EE (1.89 g)	0	34	0
other	Anxiety	Nervous system disorders	DHA EE (1.89 g) and Vitamin E (1000 mg)	0	67	0
other	Anxiety	Nervous system disorders	Placebo	1	70	1
other	Hypertonic Bladder	Renal and urinary disorders	Vitamin E (1000 mg)	0	34	0
other	Hypertonic Bladder	Renal and urinary disorders	DHA EE (1.89 g)	0	34	0
other	Hypertonic Bladder	Renal and urinary disorders	DHA EE (1.89 g) and Vitamin E (1000 mg)	0	67	0
other	Hypertonic Bladder	Renal and urinary disorders	Placebo	1	70	1
other	Pyrexia	Nervous system disorders	Vitamin E (1000 mg)	0	34	0
other	Pyrexia	Nervous system disorders	DHA EE (1.89 g)	1	34	1

1 to 10 of 336Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vitamin E (1000 mg)	0	34
Total, all-cause mortality	DHA EE (1.89 g)	0	34
Total, all-cause mortality	DHA EE (1.89 g) and Vitamin E (1000 mg)	0	67
Total, all-cause mortality	Placebo	1	70
Total, other adverse events	Vitamin E (1000 mg)	6	34
Total, other adverse events	DHA EE (1.89 g)	17	34
Total, other adverse events	DHA EE (1.89 g) and Vitamin E (1000 mg)	18	67
Total, other adverse events	Placebo	25	70
Total, serious adverse events	Vitamin E (1000 mg)	0	34
Total, serious adverse events	DHA EE (1.89 g)	0	34

1 to 10 of 12Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04198805

GET https://conductscience.org/api/trials/v1/NCT04198805/registered?page=2

API reference For AI assistants