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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring non-alcoholic fatty liver- vitamin D

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • National hepatology and tropical medicine research instituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Placebo

Cholecalciferol

Arm Description

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

Group 2: 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.

Outcomes

Primary Outcome Measures

Efficacy of cholecalciferol on glycaemic control parameters in non alcoholic fatty liver disease
Decrease in glycated haemoglobin in NAFLD patients

Secondary Outcome Measures

Efficacy of cholecalciferol on the degree of steatosis in non alcoholic fatty liver disease
Decrease in the degree of steatosis imaged by ultrasonography

Full Information

First Posted
October 31, 2022
Last Updated
November 3, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05613192
Brief Title
Effectiveness of Inactive Vitamin D Supplementation in Non-Alcoholic Fatty Liver Disease Patients
Official Title
The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients. A Randomized Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
non-alcoholic fatty liver- vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Group 1: patients received the standard conventional therapy in addition to placebo for 4 months. Group 2: patients received 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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Study medications were given to the patients by an unblinded pharmacist to ensure the right treatment assignment, however this pharmacist was not included in the outcome assessment. All patients were diagnosed with NAFLD depending on abdominal ultrasonography performed by a radiologist where the liver brightness and liver parenchyma with diffuse echogenicity in confirm the diagnosis.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Group 1: patients receive the standard conventional therapy in addition to placebo for 4 months.
Arm Title
Cholecalciferol
Arm Type
Experimental
Arm Description
Group 2: 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.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
native vitamin D
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of cholecalciferol on glycaemic control parameters in non alcoholic fatty liver disease
Description
Decrease in glycated haemoglobin in NAFLD patients
Time Frame
at Baseline and at week 16
Secondary Outcome Measure Information:
Title
Efficacy of cholecalciferol on the degree of steatosis in non alcoholic fatty liver disease
Description
Decrease in the degree of steatosis imaged by ultrasonography
Time Frame
at Baseline and at week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa El Borolossy, phd
Phone
01227052880
Email
radwa.maher14@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radwa El Borolossy
Organizational Affiliation
Faculty of pharmacy Ain Shams university
Official's Role
Principal Investigator
Facility Information:
Facility Name
National hepatology and tropical medicine research institute
City
Cairo
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radwa El Borolossy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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