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

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ClinicalTrials.gov Identifier: NCT02962297
Recruitment Status : Active, not recruiting
First Posted : November 11, 2016
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
R&G Pharma Studies Co.,Ltd.
The Affiliated Hospital of Hangzhou Normal University
Information provided by (Responsible Party):
Zhejiang Medicine Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
NASH (Non-Alcoholic Steatohepatitis) Drug: Vitamin E softgel Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: treatment group
Vitamin E softgel,100mg,Tid,orally, 96 weeks. All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
Drug: Vitamin E softgel
All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).

Placebo Comparator: placebo group
A 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).
Drug: Placebo

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





Primary Outcome Measures :
  1. Improvement in hepatic histology [ Time Frame: after 96 weeks of treatment ]
    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 and ③ no worsening of fibrosis stages.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18 -75, no limitation for ethnic and gender
  2. Body Mass Index(BMI) < 35 kg/m2
  3. 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.
  4. Fibrosis stage 0-3 according to nonalcoholic steatohepatitis clinical research network(NASH CRN).
  5. 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).
  6. The lab test results should meet the requirements:

    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 %

  7. 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.
  8. 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.
  9. 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
  10. Men must agree to use an effective form of birth control during the trial(at least include one barrier contraceptive method)
  11. All participants are needed to sign the informed consent form.

Exclusion Criteria:

  1. Evidence of other form of acute or chronic liver disease. (Virus hepatitis, Hereditary hemochromatosis, Hepatolenticular degeneration, Alcoholic liver disease, Drug-induced hepatopathy).
  2. History of diabetic mellitus or use of antidiabetic drugs.
  3. Known heart failure of New York Heart Association class 2, 3, or 4.
  4. Wear of cardiac pacemaker.
  5. Hypothyroidism (TSH > 2 times of upper normal limit).
  6. History of disease affecting drug absorption, distribution, metabolism (inflammatory bowel disease, gastrointestinal surgery, chronic pancreatitis, gluten allergy, vagotomy).
  7. 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).
  8. Positivity of antibody to Human Immunodeficiency Virus.
  9. Inability to safely obtain liver biopsy.
  10. Known intolerance to vitamin E
  11. Inability to fill out diary card, to manage diet and exercise, poor compliance.
  12. Dependence or abuse of alcohol and/or drugs.
  13. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962297


Locations
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China, Beijing
Beijing Ditan Hospital Capital Medical University
Beijin, Beijing, China
China
302 Military Hospital of China
Beijing, China
Beijing YouAn Hospital Capital Medical Univercity
Beijing, China
West China Hospital, Sichuan university
Chengdu, China
The first Affiliated Hospital, Sun Yat-sen University
Guangdong, China
Guangdong Provincial Chinese Medicine Hospital
Guangzhou, China
Nanfang Hospital
Guangzhou, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
Southwest Medical University Affiliated
Luzhou, China
The Second Hospital of Nanjing
Nanjing, China
The First Hospital of China Medical University
Shenyang, China
The second people's Hospital of Tianjin
Tianjin, China
The First Affiliated Hospital of Medical University
Urumqi, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhu, China
General Hospital Ningxia Medical
Yinchuan, China
Sponsors and Collaborators
Zhejiang Medicine Co., Ltd.
R&G Pharma Studies Co.,Ltd.
The Affiliated Hospital of Hangzhou Normal University
Investigators
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Principal Investigator: Junping Shi, Phd The Affiliated Hospital of Hangzhou Normal University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhejiang Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02962297     History of Changes
Other Study ID Numbers: VENS
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Keywords provided by Zhejiang Medicine Co., Ltd.:
Vitamin E, Non Diabetic

Additional relevant MeSH terms:
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Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents