Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

NCT ID: NCT07104786

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2024-05-23

Brief Summary

This study was conducted on patients presenting to Mayo Hospital, Lahore from 24th August, 2023 till 23rd May, 2024. Ninety patients conforming to the inclusion criteria were selected via simple random sampling technique and divided into two groups. Group A received Obeticholic acid 10mg once a day and Group B received Vitamin E 400mg twice a day. Both treatments were given for 6 months alongwith clear written and informed instructions regarding lifestyle modification. Patients were followed at 3 and 6 months with ultrasound abdomen and serum alanine transferase levels.

Detailed Description

This study was conducted in the Liver Clinic, patients presenting to the out-patients department and admitted on the Medical floor of Mayo Hospital, Lahore after taking approval from the Institutional Review Board of King Edward Medical University (KEMU) No. 166/RC/KEMU, dated 08-06-2023. A sample size of 90 patients (45 patients in each group) was estimated using 5% level of significance, 90% power of test with expected percentage improvement of fibrosis by ≥ 1 grade in obeticholic acid 10mg as 21% and vitamin E as 50%. Simple random sampling technique was employed in patient selection. Consenting adults of either gender between 18-75 years of age, diagnosed to have any grade of NAFLD on ultrasonography (Grade 1 to 3) and raised ALT >1.5 times the upper normal limit. (Normal reference <40 IU in males, <32 IU females) were included in the study. Patients with significant alcohol intake (more than 20 g/day in women and >30g/day in men), history of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, oral contraceptive pills), patients with co-morbid conditions like Diabetes, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Congestive Cardiac Failure, Hypothyroidism were excluded from the study. Pregnant and lactating females, patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension, patients taking drugs known to have significant interaction with Obeticholic acid or vitamin E including cholestyramine, theophylline and colestipol were also excluded from the study protocol. After taking informed written and verbal consent, all patients conforming to the selection criteria were enrolled in the study. The patients were randomly enrolled into two groups of 45 patients each, by computer generated lottery method. Demographic details along with initial investigations were obtained i.e., liver function test (ALT) and Ultrasound Abdomen.

Group A patients were treated with Obeticholic acid 10mg once a day whereas Group B patients were treated with Vitamin E 400mg twice a day. Total duration of treatment was 6 months. Both groups of patients were advised dietary and lifestyle modification through a separate handout and counselling session. The patients were followed up at 3 and 6 months, at 3 months to ensure compliance to lifestyle and dietary modifications and medication, also ALT levels were checked.

At 6 months follow-up, patients were subjected to ultrasound evaluation as well as ALT level measurement. Data was recorded on a predesigned proforma. Effectiveness was defined in terms of improvement on ultrasonography by at least one grade or reduction of ALT by at least 25% from the baseline or both. All patients were guided to report if they experienced any adverse effects of medications. Non-compliance to medication due to any cause resulted in exclusion from the study.

Data was entered and analyzed using computer software SPSS 26.0 version. Quantitative variables like age, weight, ALT levels were presented as mean ± SD. Qualitative variables like gender, grade of NAFLD were presented as frequency and percentage. Independent sample t test was used to compare pre and post treatment ALT levels in both the groups. Chi square was applied for comparison of NAFLD grading pre and post treatment in both groups. p-value ≤0.05 was taken as significant.

Conditions

Non Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Obeticholic acid (OCA) 10mg, Group A

45 patients received 10mg of Obeticholic acid daily for 6 months

Group Type: EXPERIMENTAL

Obeticholic Acid 10 MG

Intervention Type: DRUG

10mg OCA was given once daily for 6 months

Vitamin E 400mg twice daily, Group B

45 patients received 400mg of Vitamin E twice daily for 6 months

Group Type: ACTIVE_COMPARATOR

Vitamin E 400mg

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E 400mg was given twice daily for 6 months

Interventions

Obeticholic Acid 10 MG

10mg OCA was given once daily for 6 months

Intervention Type: DRUG

Vitamin E 400mg

Vitamin E 400mg was given twice daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

OCA; Evion

Eligibility Criteria

Inclusion Criteria

• Consenting adults of either gender between 18-75 years of age
• Any grade of NAFLD on ultrasonography (Grade 1 to 3)
• Raised ALT >1.5 times the upper normal limit. (Normal reference <40 IU in males, <32 IU females)

Exclusion Criteria

• Patients with significant alcohol intake (more than 20 g/day in women and >30g/day in men)
• History of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, oral contraceptive pills)
• Patients with co-morbid conditions like Diabetes, Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Congestive Cardiac Failure, Hypothyroidism
• Pregnant and lactating females
• Patients with history of recent myocardial infarction, cirrhosis (decompensated liver) and portal hypertension
• Patients taking drugs known to have significant interaction with Obeticholic acid or vitamin E including cholestyramine, theophylline and colestipol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: lead

Responsible Party

Tazeen Nazar

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tazeen Nazar, MBBS,FCPSMed

Role: STUDY_DIRECTOR

King Edward Medical University

Locations

King Edward Medical University, Mayo Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

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Other Identifiers

No.166/RC/KEMU Date 08/06/2023

Identifier Type: -

Identifier Source: org_study_id