NCT04977661

Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients

A Randomized Study to Compare the Efficacy of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Patients With Non-alcoholic Fatty Liver Disease Using (IL6 and CCL2) as a Predictors of Non-alcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

We conducted a 3-month, randomized, single-blind study in 102 Egyptian NASH patients who were divided into three groups; group 1 included 34 patients received Vit. E 400 mg twice a day, group 2 included 34 patients received UDCA 250 mg twice a day and group 3 included 34 patients received PTX 400 mg twice daily for 3 months. The following parameters were measured both before and after intervention intake; liver aminotransferases (AST, ALT), cytokine and chemokine (IL6 and CCL2/MPC-1), albumin, total bilirubin, direct bilirubin, total cholesterol, triglyceride, LDL, HDL.

Detailed description

This was a 3-month, prospective, randomized, and single blind study. Participants were recruited from the outpatient clinic and hepatology, gastroenterology and infectious diseases department at Kafrelsheikh University Hospital between February 2020 and January 2021. Two-hundred and five Egyptian patients diagnosed with NAFLD with potential clinical inclusion criteria were invited for a screening session to determine their eligibility for the study. Patients were enrolled in the study if they are \> 18 years old, had evidence for NASH; persistently elevated alanine aminotransferase (ALT) \>1.5 times the upper limit of normal), imaging (ultrasound) showing fatty infiltration, and histological evidence of NASH after biopsy (macrovascular steatosis, ballooning degeneration of hepatocytes, scattered lobular inflammation and apoptotic bodies).One hundred and forty-six patients were excluded from the study either because they did not meet the inclusion criteria (n = 135) or refused to enroll in the study (n =11). Qualifying participants (n = 102) were randomly assigned to one of the three treatment groups using a computer-generated randomization sequence. Group I (n = 34) received 400 IU Vitamin E (Vitamin E 400 IU®, MEPACO Pharmaceutical Company, Sharqia, Egypt) twice daily for 3 months. Group II (n =34) received 250 mg Ursodeoxycholic acid (Ursofalk 250 mg®, MINAPHARM Pharmaceutical Company, Cairo, Egypt) twice daily for 3 months. Group III (n = 34) received 400 mg sustained release (SR) Film-Coated Tablets of pentoxifylline (Trental 400 mg®, SANOFI Pharmaceutical Company, Cairo, Egypt) twice daily for 3 months. Patients were followed up every week to ensure compliance, drug adherence and to report side effects or drop out from the study.The following parameters were measured both before and after intervention intake; liver aminotransferases (AST, ALT), cytokine and chemokine (IL6 and CCL2/MPC-1), albumin, total bilirubin, direct bilirubin, total cholesterol, triglyceride, LDL, HDL.

Conditions

• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	Vitamin E	Vitamin E is one of the body's most effective chain-breaking antioxidants that has shown to delay the pathogenesis of NASH.
DRUG	Ursodeoxycholic acid	is a metabolic by-product of intestinal bacteria and has been proven to be useful in the non-surgical treatment of cholesterol gallstones and primary biliary cirrhosis (PBC)
DRUG	Pentoxifylline	it is a well-tolerated medication that improves blood viscosity and erythrocyte rheological characteristics in individuals with peripheral vascular disease 20. In addition, PTX is a nonspecific phosphodiesterase inhibitor that increases cyclic adenosine monophosphate (cAMP) levels while decreasing TNF-a gene transcription

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-05-20
• Completion: 2021-01-10
• First posted: 2021-07-27
• Last updated: 2021-07-27

Locations

1 site across 1 country: Egypt