NAFLDPhase 2NCT03669133
Vitamin E for NASH Treatment in HIV Infected Individuals
A Phase 2 study testing Vitamin E in people with NAFLD and NASH - Nonalcoholic Steatohepatitis, run by Indiana University at 2 sites in United States.
Trial summary
The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition (fatty liver) gets better, worse, or stays the same from taking Vitamin E. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NAFLD, NASH - Nonalcoholic Steatohepatitis, HIV Infections
- What is being tested?
- Vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2019to 8 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females ≥18 years with biopsy-proven NASH within 6 months prior to enrollment
- histological diagnosis of NASH will be confirmed by an experienced liver pathologist before study entry
- HIV infection
- stable dose of anti-diabetic agents and ART in the 3 months preceding enrollment and expected by the physician treating diabetes and HIV to remain on stable medications during the study
- willingness to participate in the study
- ability to understand and give informed consent for participation
Who cannot join
- Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilson disease, hemochromatosis, etc.)
- average alcohol consumption >3 drinks/day for men or >2 drinks/day for women in the 6 months prior to enrollment.
- Alcohol Use Disorder Identification Test (AUDIT) score of ≥8
- evidence of cirrhosis on histology or imaging
- ongoing use of medications known to cause hepatic steatosis (e.g., corticosteroids, amiodarone, methotrexate, tetracycline, tamoxifen, estrogens at doses greater than those used for birth control, anabolic steroids, or valproic acid)
- prior bariatric surgery
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- severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness)
- allergy to vitamin E
- use of vitamin E or multivitamins containing vitamin E in the three months preceding enrollment
- use of drugs with potential effect on NASH such as ursodeoxycholic acid, S-adenosylmethionine (SAM-e), betaine, pentoxifylline, or milk thistle in the three months prior to enrollment.
- changing doses of statins (simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, fenofibrate) in the three months prior enrollment.
- illicit substance abuse within the past twelve months
- breast feeding, pregnancy, inability or unwillingness to practice contraception for the duration of the study
- contraindications for the MRI procedure (e.g., prostheses, severe claustrophobia)
- poorly controlled diabetes with A1C >8.5 within in the last six months
- use of total parenteral nutrition in the 6 months preceding liver biopsy or enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition (fatty liver) gets better, worse, or stays the same from taking Vitamin E.
Read the detailed description
The investigators will conduct a proof-of-concept clinical trial to evaluate the efficacy of vitamin E for treatment of non-alcoholic steatohepatitis (NASH) in persons living with HIV. Hypothesis: Vitamin E will improve radiographically measured hepatic fat content and circulating markers of liver inflammation and injury in persons living with HIV who have NASH.
- Perform a pilot randomized placebo controlled trial of vitamin E 800 IU/daily for 6 months in 56 persons living with HIV with biopsy-proven NASH B. Measure change in liver fat content by magnetic resonance proton-density fat fraction (Primary outcome) C. Determine the impact of vitamin E treatment on noninvasive markers of hepatic and systemic inflammation, hepatic fibrosis, and systemic oxidative stress (Secondary outcomes) D. Define baseline hepatic gene expression signatures predictive of response to therapy.
Upon completion, the proposed clinical trial may establish vitamin E as an excellent and inexpensive candidate for further development as a treatment for NASH in persons living with HIV.
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, HIV Infections
- Being tested
- Vitamin E, Placebo
- Keywords
- Fatty liver, NAFLD, NASH, HIV, Vitamin E
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, HIV Infections, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Vitamin E 800 IU/daily
PlaceboDrug
Matching placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Vitamin E 800 IU/daily for 24 weeks Receives: Drug: Vitamin E |
| Group B | Placebo comparator | Matching placebo for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction
change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis
Measured: at randomization visit (study day 1) and end of study visit (week 24)
Secondary outcomes (3)
Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis
This outcome measure reflects the change in liver stiffness in transient elastrography via FibroScan is measured in (kPa) for study participants at two study time points
Measured: change from baseline (first screening visit) to the end of study visit (week 24)
Impact of Treatment on ALT as a Noninvasive Marker of Hepatic Inflammation
This measure reflects the change in ALT(IU/L) value for study participants at two study time points
Measured: at randomization visit (study day 1) and end of study visit (week 24)
Impact of Treatment on AST as a Noninvasive Marker of Hepatic Inflammation
This measure reflects the change in AST(IU/L) value for study participants at two study time points
Measured: Change in AST from study randomization (day 1) through the end of study visit (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Oct 2019
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Why it stopped: lack of coordinator resources and lack of access to study resources during and due to the COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Vitamin E 800 IU/daily for 24 weeks. (total of 28 subjects) Group B: Matching placebo for 24 weeks (total of 28 subjects)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Gawrieh, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669133
- Sponsor's protocol ID
- 1807274844
- Status last verified
- Jul 2023
- First submitted
- 5 Sep 2018
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin E for NASH Treatment in HIV Infected Individuals
- ClinicalTrials.gov ID
- NCT03669133
- Acronym / sponsor ID
- 1807274844
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, HIV Infections
- Keywords
- Fatty liver, NAFLD, NASH, HIV, Vitamin E
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of coordinator resources and lack of access to study resources during and due to the COVID pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 25 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition (fatty liver) gets better, worse, or stays the same from taking Vitamin E.
Detailed description
The investigators will conduct a proof-of-concept clinical trial to evaluate the efficacy of vitamin E for treatment of non-alcoholic steatohepatitis (NASH) in persons living with HIV. Hypothesis: Vitamin E will improve radiographically measured hepatic fat content and circulating markers of liver inflammation and injury in persons living with HIV who have NASH.
- Perform a pilot randomized placebo controlled trial of vitamin E 800 IU/daily for 6 months in 56 persons living with HIV with biopsy-proven NASH B. Measure change in liver fat content by magnetic resonance proton-density fat fraction (Primary outcome) C. Determine the impact of vitamin E treatment on noninvasive markers of hepatic and systemic inflammation, hepatic fibrosis, and systemic oxidative stress (Secondary outcomes) D. Define baseline hepatic gene expression signatures predictive of response to therapy.
Upon completion, the proposed clinical trial may establish vitamin E as an excellent and inexpensive candidate for further development as a treatment for NASH in persons living with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group A: Vitamin E 800 IU/daily for 24 weeks. (total of 28 subjects) Group B: Matching placebo for 24 weeks (total of 28 subjects)
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Vitamin EVitamin E 800 IU/daily for 24 weeks |
| Group B | Placebo comparator | Drug: PlaceboMatching placebo for 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males and females ≥18 years with biopsy-proven NASH within 6 months prior to enrollment
- histological diagnosis of NASH will be confirmed by an experienced liver pathologist before study entry
- HIV infection
- stable dose of anti-diabetic agents and ART in the 3 months preceding enrollment and expected by the physician treating diabetes and HIV to remain on stable medications during the study
- willingness to participate in the study
Key exclusion criteria (16 listed)
- Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilson disease, hemochromatosis, etc.)
- average alcohol consumption >3 drinks/day for men or >2 drinks/day for women in the 6 months prior to enrollment.
- Alcohol Use Disorder Identification Test (AUDIT) score of ≥8
- evidence of cirrhosis on histology or imaging
- ongoing use of medications known to cause hepatic steatosis (e.g., corticosteroids, amiodarone, methotrexate, tetracycline, tamoxifen, estrogens at doses greater than those used for birth control, anabolic steroids, or valproic acid)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin EVitamin E 800 IU/daily | Drug | Group A |
| PlaceboMatching placebo daily | Drug | Group B |
Primary outcome
Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction
Time frame: at randomization visit (study day 1) and end of study visit (week 24)
change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis
3 secondary outcomes
Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis
Time frame: change from baseline (first screening visit) to the end of study visit (week 24)
Impact of Treatment on ALT as a Noninvasive Marker of Hepatic Inflammation
Time frame: at randomization visit (study day 1) and end of study visit (week 24)
Impact of Treatment on AST as a Noninvasive Marker of Hepatic Inflammation
Time frame: Change in AST from study randomization (day 1) through the end of study visit (week 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin E in people with NAFLD and NASH - Nonalcoholic Steatohepatitis, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction (time frame: at randomization visit (study day 1) and end of study visit (week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.