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

Not Applicable

Completed

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Drug: Obeticholic Acid 10 MG; Dietary Supplement: Vitamin E 400mg

• Registration Number: NCT07104786
• Lead Sponsor: King Edward Medical University

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.

Study Timeline

• Study Start: 2023-08-24
• Primary Completion: 2023-11-23
• Study Completion: 2024-05-23
• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obeticholic acid (OCA) 10mg, Group A	Obeticholic Acid 10 MG	45 patients received 10mg of Obeticholic acid daily for 6 months
Vitamin E 400mg twice daily, Group B	Vitamin E 400mg	45 patients received 400mg of Vitamin E twice daily for 6 months

Primary Outcome Measures

Name	Time	Method
Reduction of ALT levels	6 months	25% reduction of ALT levels from baseline
Change in grade of NAFLD on ultrasound	6 months	Improvement/ reduction on ultrasonography of at least one grade of NAFLD from baseline

Trial Locations

Locations (1)

King Edward Medical University, Mayo Hospital, Lahore; 🇵🇰 Lahore, Punjab, Pakistan