Vitamin E Versus Placebo for the Treatment of Non Diabetic Patients With Nonalcoholic Steatohepatitis
NCT ID: NCT02962297
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2016-12-31
2021-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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treatment group
Vitamin E softgel,100mg,Tid,orally, 96 weeks. All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
Vitamin E softgel
All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
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).
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
Interventions
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Vitamin E softgel
All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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R&G Pharma Studies Co.,Ltd.
INDUSTRY
The Affiliated Hospital of Hangzhou Normal University
OTHER
Zhejiang Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Junping Shi, Phd
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Hangzhou Normal University
Locations
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Beijing Ditan Hospital Capital Medical University
Beijin, Beijing Municipality, 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
Ürümqi, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhu, , China
General Hospital Ningxia Medical
Yinchuan, , China
Countries
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References
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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.
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.
Other Identifiers
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VENS
Identifier Type: -
Identifier Source: org_study_id
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