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NASH (Non-Alcoholic Steatohepatitis)NCT02962297

Vitamin E Versus Placebo for the Treatment of Non Diabetic Patients With Nonalcoholic Steatohepatitis

A study testing Vitamin E softgel in people with NASH (Non-Alcoholic Steatohepatitis), run by Zhejiang Medicine Co., Ltd. at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults with NASH compared to treatment with placebo in China. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NASH (Non-Alcoholic Steatohepatitis)
What is being tested?
Vitamin E softgel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
15 sitesChina
Study dates
Dec 2016to 17 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

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

  • Age: 18 -75, no limitation for ethnic and gender
  • Body Mass Index(BMI) < 35 kg/m2
  • Patients with nonalcoholic steatohepatitis (NASH) based on liver biopsy obtained within 6 months before randomization. The histological evidence of NASH was defined as Non - alcoholic fatty liver disease activity score（NAS）≥ 4 (according to Nonalcoholic Steatohepatitis Clinical Research Network, NASH CRN) with a minimum 1 score for steatosis, lobular inflammation, and hepatocyte ballooning respectively.
  • Fibrosis stage 0-3 according to nonalcoholic steatohepatitis clinical research network（NASH CRN).
  • Without history of significant alcohol consumption for a period of more than 3 months within 5 years (<10 g/day for female and < 20 g/day for male).
  • The lab test results should meet the requirements:
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  • ① Alanine aminotransferase （ALT） < 5 times of normal upper limit
  • ② Creatinine (Cr)< normal upper limit
  • ③ Albumin （ALB）> 3.5g/L
  • ④ International normalized ratio（INR）= 0.8-1.3
  • ⑤ Fasting plasma glucose(FPG) < 126mg/dL（7mmol/L） and/or 2h postprandial plasma glucose (PPG) < 200mg/dL（11.1mmol/L）and/ or HbA1C < 6.5 %
  • If a participant with hypertension, he/she was required a stable antihypertensive drug(s) to keep blood pressure stable.(blood pressure < 140/90 mmHg) 3 months prior to randomization.
  • If a participant using a statin or fibrate, he/she was required on a stable dose to keep lipid stable (triglyceride(TG) < 1.7 mmol/L, total cholesterol (TC) < 5.72 mmol/L, LDL-c < 3.64 mmol/L) 3 months prior to randomization.
  • Women of childbearing potential: negative pregnancy test during screening or at randomization or willingness to use an effective form of birth control during the trial(at least include one barrier contraceptive method) and not breast feeding
  • Men must agree to use an effective form of birth control during the trial(at least include one barrier contraceptive method)
  • All participants are needed to sign the informed consent form.

Who cannot join

  • Evidence of other form of acute or chronic liver disease. (Virus hepatitis, Hereditary hemochromatosis, Hepatolenticular degeneration, Alcoholic liver disease, Drug-induced hepatopathy).
  • History of diabetic mellitus or use of antidiabetic drugs.
  • Known heart failure of New York Heart Association class 2, 3, or 4.
  • Wear of cardiac pacemaker.
  • Hypothyroidism (TSH > 2 times of upper normal limit).
  • History of disease affecting drug absorption, distribution, metabolism (inflammatory bowel disease, gastrointestinal surgery, chronic pancreatitis, gluten allergy, vagotomy).
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  • Use of anti-NASH drugs within 3 months before randomization (metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitor, glucagon-like peptide-1(GLP-1), sodium glucose contransporter2(SGLT2), S-adenosylmethionine -e(SAM-e), polyene phosphatidyl choline, glycyrrhizin, bicyclol, reduced glutathione, betaine, fish oil, silymarin,oberbic acid/ursodeoxycholic acid (OCA/UDCA), phosphodiesterase (PDE)-inhibitor, gemfibrozil, vitamin E, long term antibiotic (>1 week).
  • Positivity of antibody to Human Immunodeficiency Virus.
  • Inability to safely obtain liver biopsy.
  • Known intolerance to vitamin E
  • Inability to fill out diary card, to manage diet and exercise, poor compliance.
  • Dependence or abuse of alcohol and/or drugs.
  • Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijin, Beijing Municipality

  • 302 Military Hospital of China

    Beijing

  • Beijing YouAn Hospital Capital Medical Univercity

    Beijing

  • West China Hospital, Sichuan university

    Chengdu

  • The first Affiliated Hospital, Sun Yat-sen University

    Guangdong

  • Guangdong Provincial Chinese Medicine Hospital

    Guangzhou

  • Nanfang Hospital

    Guangzhou

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou

  • Southwest Medical University Affiliated

    Luzhou

  • The Second Hospital of Nanjing

    Nanjing

  • The First Hospital of China Medical University

    Shenyang

  • The second people's Hospital of Tianjin

    Tianjin

  • The First Affiliated Hospital of Medical University

    Ürümqi

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhu

  • General Hospital Ningxia Medical

    Yinchuan

Other trials in China

About this study

Official title: VENS is a Multicenter, Randomized, Double-masked, Placebo Parallel Controlled Trial to Evaluate the Efficacy and Safety of Treatment With Vitamin E Softgel in Non Diabetic Adults With NASH Compared to Treatment With Placebo in China

VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults with NASH compared to treatment with placebo in China.

Being tested
Vitamin E softgel, Placebo
Keywords
Vitamin E, Non Diabetic
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin E softgelDrug

    All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).

  • PlaceboDrug

    All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).

    Height and weight, waist-to-hip ratio Review of diet and exercise

Study groups in NCT02962297
Study groupRoleWhat they receive
treatment groupExperimentalVitamin E softgel,100mg,Tid,orally, 96 weeks. All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
Receives: Drug: Vitamin E softgel
placebo groupPlacebo comparatorA similar appearing placebo softgel , Vitamin E -Placebo, Tid, orally, 96 weeks, All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in hepatic histology

    Improvement in hepatic histology after 96 weeks of treatment as determined by liver biopsies compared to baseline. (Independent pathological evaluation committee was charged with interpreting of the histological characteristic and that allows for assessment of changes with therapy). The definition of histologic improvement requires all three of the following criteria: ① either improvement in NAS by at least 2 points or post-treatment NAS of 3 points or less, ② at least 1 point improvement in the score for ballooning or lobular inflammation③ no worsening of fibrosis stages.

    Measured: after 96 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion9 Nov 2020
  4. Study completion17 Dec 2021

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02962297
Sponsor's protocol ID
VENS
Status last verified
Nov 2020
First submitted
27 Oct 2016
Last updated
3 Apr 2023
Results posted
No

Publications

  • Song Y, Ni W, Zheng M, Sheng H, Wang J, Xie S, Yang Y, Chi X, Chen J, He F, Fan X, Mi Y, Zhang J, Wang B, Bai L, Xie W, Zhong B, Yeo YH, Rui F, Zang S, Li J, Shi J; Chinese NAFLD Clinical Research Network (CNAFLD CRN). Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study. Cell Rep Med. 2025 Feb 18;6(2):101939. doi: 10.1016/j.xcrm.2025.101939.

    PubMed 39970876

  • Zang S, Chen J, Song Y, Bai L, Chen J, Chi X, He F, Sheng H, Wang J, Xie S, Xie W, Yang Y, Zhang J, Zheng M, Zou Z, Wang B, Shi J; Chinese NAFLD Clinical Research Network (CNAFLD CRN). Haptoglobin Genotype and Vitamin E Versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis in China: A Multicenter, Randomized, Placebo-Controlled Trial Design. Adv Ther. 2018 Feb;35(2):218-231. doi: 10.1007/s12325-018-0670-8. Epub 2018 Feb 6.

    PubMed 29411270

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin E softgel in people with NASH (Non-Alcoholic Steatohepatitis), run by Zhejiang Medicine Co., Ltd. at 15 sites in China.

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 16 inclusion and 13 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: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Improvement in hepatic histology (time frame: after 96 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02962297, which also lists 2 linked publications.

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 3 Apr 2023.

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