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
Initiatives
-
This clinical trial of vitamin E versus placebo for the treatment of nondiabetic patients with nonalcoholic steatohepatitis (VENS) is conducted to evaluate (a) the efficacy and safety of treatment with vitamin E softgel (300 mg/day) determined from standardized histologic scoring of liver biopsies, (b) whether treatment with vitamin E improves biochemical parameters, cytokines, anthropometric parameters, controlled attenuation parameter (CAP), and transient elastography (TE) values determined by Fibroscan and health-related quality of life (SF-36), (c) whether the efficacy of vitamin E treatment is associated with the Hp genotype in nondiabetic adults with NASH.
Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
- Start Year
- 2016
- Funding
- Zhejiang Medicine Co
Design
- Study design
- Clinical trial cohort
Marker Paper
Zang S, Chen J, Song Y, et al. 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;35(2):218‐231. doi:10.1007/s12325-018-0670-8 Forma
PUBMED 29411270
Recruitment
- Sources of Recruitment
-
- Individuals
Number of participants
- Number of participants
- 120
- Number of participants with biosamples
Access
Availability of data and biosamples
Data | |
Biosamples | |
Other |
Timeline
Population
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.
Selection Criteria
- Minimum age
-
19
- Maximum age
-
75
- Newborns
- Twins
- Countries
-
- China
- Territory
- Beijing
- Ethnic Origin
-
- Health Status
-
- 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: 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.
Recruitment
- Sources of recruitment
-
- General population
Number of participants
- Number of participants
- 120
- Number of participants with biosamples
Data Collection Event
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.
- Start Date
-
2016-12
- End Date
-
2021-05
- Data sources
-
-
Mobile data collection
- Mobile phone
- Smartphone
- Smartphone apps
-
Mobile data collection