Effectiveness of Inactive Vitamin D Supplementation in Non-Alcoholic Fatty Liver Disease Patients

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients. A Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613192
• Other study ID #: NHTMRI-IRB 10-22
• Status: Recruiting
• Phase: Phase 3
• Start date: October 31, 2022
• Est. completion date: March 5, 2023

Study information

• Verified date: November 2022
• Source: Ain Shams University
• Contact: Radwa El Borolossy, phd
• Phone: 01227052880
• Email: radwa.maher14[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of work The aim of our study is to assess the effectiveness and safety of high oral loading dose of inactive vitamin D supplementation on the clinical parameters related to liver steatosis, glycaemic control, insulin resistance and metabolic profile in NAFLD patients

Description:

Aim of work The aim of our study is to assess the effectiveness and safety of high oral loading dose of inactive vitamin D supplementation on the clinical parameters related to liver steatosis, glycaemic control, insulin resistance and metabolic profile in NAFLD patients

Patients and Methods The present study is prospective, simply (via computer generated sequence) randomized controlled double blinded study, will be conducted on NAFLD patients in the outpatient liver clinics of EL Sahel Teaching hospital, Cairo, Egypt, Inclusion criteria: To be included in the study, patients have to fulfil the following inclusion criteria: male or female patients >19 years of age; presence of fatty liver detected by upper abdominal ultrasound echography (US) and with diagnosis of T2D according to ADA 2019 criteria.

Exclusion Criteria: The main exclusion criteria from the study are as follows: Pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, Wilson's disease), drug induced hepatitis, chronic enteropathies, Chronic kidney disease, hyper/hypoparathyroidism, known hypersensitivity to cholecalciferol.

Hundred eligible patients will be included into the study and randomized by simple randomization into either of the 2 groups:

Group 1: 50 patients receive the standard conventional therapy in addition to placebo for 4 months.

Group 2: 50 patients receive the standard conventional therapy in addition to a single oral dose of cholecalciferol 300,000 IU followed by oral cholecalciferol 800 IU daily for 4 months.

The following laboratory tests will be measured: a- Glycaemic control: Fasting blood glucose (FBG mg/dl), glycated haemoglobin (HbA1C%), Fasting insulin (mU/L), Insulin resistance index calculated by the homeostasis model assessment insulin resistance (HOMA-IR) method using the product of fasting insulin and fasting plasma glucose divided by 405. The cut off value of HOMA-IR is more than 1.64.

b-Liver function tests: Alanine transaminase (ALT U/L), Aspartate transaminase (AST U/L), Albumin (g/dl), Gamma glutamyl transferase (GGT U/L), Alkaline phosphatase (ALP U/L).

c- Lipid Profile: Low density lipoprotein (LDL-C mg/dl), High density lipoprotein (HDL-C mg/dl), Triglycerides (TG mg/dl), Total cholesterol (TC mg/dl) d- Other markers: High sensitivity C reactive protein (hsCRP mg/dl), Alfa fetoprotein (AFP ng/ml), serum 25-hydroxy vitamin D (25(OH) D ng/ml) All Patients were followed up every 2 weeks by the clinical pharmacist in charge through patient encounter to ensure the compliance to the treatment regimen and to assess any adverse side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 5, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients >18 years with fatty liver diagnosis by using upper abdominal ultrasound echography (US)

• patients with T2D diagnosed according to ADA 2019 criteria and treated with metformin.

Exclusion Criteria:

• Pregnant and/or lactating women,

• excessive alcohol use (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day women),

• patients with other causes of chronic liver disease as viral hepatitis, drug induced hepatitis, autoimmune hepatitis, patients suffering of chronic kidney disease, hyper/hypoparathyroidism,

• hypersensitivity to cholecalciferol,

• hypercalcemia,

• patients taking supplementation with vitamin D,

• calcium and medications affecting calcium/vitamin D metabolism (as: anticonvulsants, glucocorticoids, antacids).

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• Cholecalciferol
patients receive the standard conventional therapy in addition to a single oral dose of cholecalciferol 300,000 IU followed by oral cholecalciferol 800 IU daily for 4 months.

Locations

Country	Name	City	State
Egypt	National hepatology and tropical medicine research institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of cholecalciferol on glycaemic control parameters in non alcoholic fatty liver disease	Decrease in glycated haemoglobin in NAFLD patients	at Baseline and at week 16
Secondary	Efficacy of cholecalciferol on the degree of steatosis in non alcoholic fatty liver disease	Decrease in the degree of steatosis imaged by ultrasonography	at Baseline and at week 16